CIDAR-3: Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01012167
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 86
• Locations: 6
• Arms: 3
• Duration (Months): 52.9
• Patients Per Site: 14.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The project is designed to address the following two primary aims:

1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of persistent negative symptoms, as measured by the SANS total score, in people with schizophrenia.

2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of cognitive impairments, as measured by improvement on a composite neurocognitive score in people with schizophrenia.

The investigators will also address the following secondary aims:

1. To determine whether people with schizophrenia treated with adjunctive oxytocin, compared to placebo, will show greater improvement on markers of negative symptom liability including: social affiliation, facial affect recognition, olfactory discrimination, initiation of smooth pursuit and latency of internally-driven saccades.

2. To determine whether people with schizophrenia treated with adjunctive Galantamine, compared to placebo, will show greater improvement on markers of cognitive impairment liability including: predictive pursuit, P50 sensory gating and visual-spatial working memory.

The investigators will address the following exploratory aims:

1. To determine whether changes in markers of negative symptom liability are correlated with changes in SANS total score.

2. To determine whether changes in markers of cognitive impairment liability are correlated with changes in the composite neurocognitive score.

3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS battery, and to determine the response to Galantamine of all cognition domains assessed by the MATRICS, which are not included in the primary neurocognitive outcome score.

4. To determine whether there is a differential response of oxytocin and Galantamine on the SANS total score, composite neurocognitive score, and with the phenotypic measures of negative symptom and cognitive impairment liability.

5. To determine whether oxytocin and Galantamine are associated with:

• adverse effects on positive or depressive symptoms;

• adverse effects on motor symptoms;

• adverse effects on laboratory and EKG measures;

• increased occurrence of side effects;

• social interest that is independent of sexual desire.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Oxytocin; Drug: Galantamine; Other: Placebo-Oxytocin; Other: Placebo-Galantamine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1: galantamine/placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Drug: Galantamine; Galantamine: 4 mg twice a day for 1 week, then 8 mg twice a day for 1 week, then 12 mg twice a day for 4 weeks; Other: Placebo-Oxytocin; Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration
Active Comparator: 2: oxytocin/placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Drug: Oxytocin; Oxytocin: 24 IU in the morning and 24 IU in the evening given by nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration; Other: Placebo-Galantamine; Placebo tablets twice a day for 6 weeks
Placebo Comparator: 3: placebo-galantamine /placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin	Other: Placebo-Oxytocin; Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration; Other: Placebo-Galantamine; Placebo tablets twice a day for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Scale for the Assessment of Negative Symptoms (SANS) Total Score [Every other week for 6 weeks]

   Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.

2. Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week [Treatment Week 0 and Week 6]

   * Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.

Secondary Outcome Measures

1. Scale for the Assessment of Negative Symptoms (SANS) - Avolition [Every other week for 6 weeks]

   Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

2. Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia [Every other week for 6 weeks]

   Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

3. Scale for the Assessment of Negative Symptoms (SANS) - Alogia [Every other week for 6 weeks]

   Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

4. Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect [Every other week for 6 weeks]

   Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.

5. Brief Psychiatric Rating Scale (BPRS) - Total Score [Every other week for 6 weeks]

   The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.

6. Brief Psychiatric Rating Scale (BPRS) - Psychosis Score [Every other week for 6 weeks]

   The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.

7. Calgary Depression Scale (CDS) - Total Score [Every other week for 6 weeks]

   Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.

8. Arizona Sexual Experience Questionnaire (ASEX) Female [Once during evaluation and once at the end of 6 weeks of study treatment]

   Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.

9. Arizona Sexual Experience Questionnaire (ASEX) Male [Once during evaluation and once at the end of 6 weeks of study treatment]

   Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.

10. Vital Signs - Diastolic Blood Pressure [Weekly for 6 weeks]

    Mean diastolic blood pressure by treatment and follow-up week

11. Vital Signs - Systolic Blood Pressure [Weekly for 6 weeks]

    Mean systolic blood pressure by treatment and follow-up week

12. Vital Signs - Weight [Weekly for 6 weeks]

    Mean weight (kg) by treatment and follow-up week

13. Vital Signs - Pulse [Weekly for 6 weeks]

    Mean sitting pulse (bpm) by treatment and follow-up week

14. Simpson-Angus Scale (SAS) [Baseline, week 3, and week 6]

    SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.

15. Abnormal Involuntary Movement Scale (AIMS) [Treatment Week 0 and Week 6]

    AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.

16. Electrocardiogram (EKG) [Once during Evaluation and once at Treatment Week 6]

    Mean corrected QT interval (QTc) by study week and treatment.

17. Barnes Akathisia Scale (BAS) - Global Score [Treatment Week 0 and Week 6]

    For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia.

18. Blood Oxytocin Levels [Treatment Week 0 and Week 6]

    Blood Oxytocin Levels by Treatment and Visit

19. Laboratory Measures - ALT/SGPT [Once during evaluation and once at the end of 6 weeks of study treatment]

    Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.

20. Laboratory Measures - AST/SGOT [Once during evaluation and once at the end of 6 weeks of study treatment]

    Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.

21. Laboratory Measures - Alkaline Phosphatase [Once during evaluation and once at the end of 6 weeks of study treatment]

    Alkaline phosphatase blood level by treatment group and visit.

22. Laboratory Measures - Calcium [Once during evaluation and once at the end of 6 weeks of study treatment]

    Calcium blood levels by treatment group and visit.

23. Laboratory Measures - Sodium [Once during evaluation and once at the end of 6 weeks of study treatment]

    Sodium blood levels by treatment group and visit.

24. Laboratory Measures - Potassium [Once during evaluation and once at the end of 6 weeks of study treatment]

    Potassium blood levels by treatment group and visit.

25. Laboratory Measures - Chloride [Once during evaluation and once at the end of 6 weeks of study treatment]

    Chloride blood levels by treatment group and visit.

26. Laboratory Measures - CO2 [Once during evaluation and once at the end of 6 weeks of study treatment]

    Carbon Dioxide (CO2) blood levels by treatment group and visit.

27. Laboratory Measures - Cholesterol [Once during evaluation and once at the end of 6 weeks of study treatment]

    Total cholesterol blood levels by treatment group and visit.

28. Laboratory Measures - HDL [Once during evaluation and once at the end of 6 weeks of study treatment]

    High-density lipoprotein (HDL) blood levels by treatment group and visit.

29. Laboratory Measures - LDL [Once during evaluation and once at the end of 6 weeks of study treatment]

    Low-density lipoprotein (LDL) blood levels by treatment group and visit.

30. Laboratory Measures - Triglycerides [Once during evaluation and once at the end of 6 weeks of study treatment]

    Triglyceride blood levels by treatment group and visit.

31. Laboratory Measures - VLDL [Once during evaluation and once at the end of 6 weeks of study treatment]

    Very low density lipoprotein (VLDL) blood levels by treatment group and visit.

32. Laboratory Measures - Glucose [Once during evaluation and once at the end of 6 weeks of study treatment]

    Glucose blood levels by treatment group and visit.

33. Laboratory Measures - Albumin [Once during evaluation and once at the end of 6 weeks of study treatment]

    Albumin blood levels by treatment group and visit.

34. Laboratory Measures - Globulin [Once during evaluation and once at the end of 6 weeks of study treatment]

    Globulin blood levels by treatment group and visit.

35. Laboratory Measures - A/G Ratio [Once during evaluation and once at the end of 6 weeks of study treatment]

    Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.

36. Laboratory Measures - Bilirubin [Once during evaluation and once at the end of 6 weeks of study treatment]

    Bilirubin blood level by treatment group and visit.

37. Laboratory Measures - Protein [Once during evaluation and once at the end of 6 weeks of study treatment]

    Protein blood level by treatment group and visit.

38. Laboratory Measures - BUN [Once during evaluation and once at the end of 6 weeks of study treatment]

    BUN blood level by treatment group and visit.

39. Side Effect Checklist (SEC) - Abdominal Pain [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group.

40. Side Effect Checklist (SEC) - Anorexia [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group.

41. Side Effect Checklist (SEC) - Bruising Easily [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group.

42. Side Effect Checklist (SEC) - Constipation [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group.

43. Side Effect Checklist (SEC) - Diarrhea [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group.

44. Side Effect Checklist (SEC) - Dizziness [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group.

45. Side Effect Checklist (SEC) - Dry Eye [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group.

46. Side Effect Checklist (SEC) - Dry Mouth [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group.

47. Side Effect Checklist (SEC) - Enuresis [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group.

48. Side Effect Checklist (SEC) - Excessive Tearing of the Eye [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group.

49. Side Effect Checklist (SEC) - Fever [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group.

50. Side Effect Checklist (SEC) - Headache [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group.

51. Side Effect Checklist (SEC) - Hyperhydrosis [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group.

52. Side Effect Checklist (SEC) - Hypersalivation [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group.

53. Side Effect Checklist (SEC) - Insomnia [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group.

54. Side Effect Checklist (SEC) - Malaise [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group.

55. Side Effect Checklist (SEC) - Mucosal Ulceration [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group.

56. Side Effect Checklist (SEC) - Nasal Irritation [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group.

57. Side Effect Checklist (SEC) - Nausea [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group.

58. Side Effect Checklist (SEC) - Rash [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group.

59. Side Effect Checklist (SEC) - Restlessness [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group.

60. Side Effect Checklist (SEC) - Sedation [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group.

61. Side Effect Checklist (SEC) - Sore Throat [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group.

62. Side Effect Checklist (SEC) - Stiffness [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group.

63. Side Effect Checklist (SEC) - Tinnitus [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group.

64. Side Effect Checklist (SEC) - Tremor [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group.

65. Side Effect Checklist (SEC) - Urticaria [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group.

66. Side Effect Checklist (SEC) - Uterine Contractions [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group.

67. Side Effect Checklist (SEC) - Vomiting [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group.

68. Side Effect Checklist (SEC) - Weight Loss [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group.

69. Side Effect Checklist (SEC) - Wheezing [Weekly for 6 weeks]

    Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group.

70. Neurocognitive Assessment Battery (MCCB) - Composite Score [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.

71. Neurocognitive Assessment Battery (MCCB) - Attention Vigilance [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. .

72. Neurocognitive Assessment Battery (MCCB) - Processing Speed [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.

73. Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.

74. Neurocognitive Assessment Battery (MCCB) - Social Cognition [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.

75. Neurocognitive Assessment Battery (MCCB) - Verbal Learning [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.

76. Neurocognitive Assessment Battery (MCCB) - Visual Learning [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.

77. Neurocognitive Assessment Battery (MCCB) - Working Memory [Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).]

    MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.

78. Positive and Negative Affect Schedule (PANAS) - Negative [Treatment Week 0 and Week 6]

    Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.

79. Positive and Negative Affect Schedule (PANAS) - Positive [Treatment Week 0 and Week 6]

    Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.

80. Reactions to Partner [Treatment Week 0 and Week 6]

    Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being "completely agree" and 5 being "completely disagree". The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.

81. Willingness to Interact [Treatment Week 0 and Week 6]

    Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being "definitely willing" and 5 being "definitely unwilling". The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any race

• Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder

• Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms

• The minimum level of negative symptoms will be defined as follows:

• Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR

• SANS alogia global item score 3 or greater

• The maximum level of psychotic, depressive, and extrapyramidal symptoms at the beginning and end of leading in:

• Brief Psychiatric Rating Scale (BPRS) psychotic factor score (4-items) less or equal to 16

• BPRS Anxiety/Depression factor score (4-items) less than or equal to 14

• Simpson-Angus-Scale (SAS) total score (13-items) less than or equal to 10

• Subjects will be required to be on the same antipsychotic(s) for two months and on the same dose for the last month

Exclusion Criteria:

• Participants with an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol

• Participants with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month.

• Participants may be treated with one or more antipsychotics, except chlorpromazine, thioridazine, or mesoridazine. These latter antipsychotics are excluded because of the concern that their anticholinergic properties may interfere with the accurate assessment of galantamine efficacy.

• Participants may not be treated with anticholinergic medications or have clinically significant extrapyramidal symptoms. Additionally, subjects treated with glycopyrrolate will be accepted.

• Female participants may not be pregnant

• Female subjects may not be taking olanzapine at doses higher than 30 mg . Male subjects may not be taking olanzapine at doses higher than 40 mg.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center	Baltimore	Maryland	United States	21201
2	Community Mental Health Centers	Baltimore	Maryland	United States	21201
3	Keypoint Community Mental Health Centers	Baltimore	Maryland	United States	21222
4	Maryland Psychiatric Research Center	Baltimore	Maryland	United States	21228
5	Maryland Psychiatric Research Center	Catonsville	Maryland	United States	21228
6	Keypoint Mental health Center	Dundalk	Maryland	United States	21222

Sponsors and Collaborators

• University of Maryland, Baltimore
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: William T Carpenter, M.D., Maryland Psychiatric Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01012167
• Other Study ID Numbers: HP-00044324; 1P50MH082999-01
• First Posted: Nov 11, 2009
• Last Update Posted: Jan 12, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Robert Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland, Baltimore: Schizophrenia, oxytocin, galantamine
• Additional relevant MeSH terms: Schizophrenia; Cognitive Dysfunction; Galantamine; Oxytocin

Study Results

Participant Flow

Pre-assignment Detail	Consented/Screened for Study-- N=86 Withdrew prior to randomization (N=28) 2 withdrew consent 26 did not meet inclusion criteria Randomized-- N=58

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Period Title: Overall Study
STARTED	17	20	21
Withdrawn Prior to Study Drug Exposure	1	0	1
Exposed to Study Drug	16	20	20
COMPLETED	15	18	17
NOT COMPLETED	2	2	4

Baseline Characteristics

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo	Total
Arm/Group Description	Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks	Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.	Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.	Total of all reporting groups
Overall Participants	16	20	20	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	20 100%	20 100%	56 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.4 (11.2)	45.8 (12.4)	42.2 (11.7)	44.9 (11.8)
Sex: Female, Male (Count of Participants)
Female	2 12.5%	6 30%	3 15%	11 19.6%
Male	14 87.5%	14 70%	17 85%	45 80.4%
Region of Enrollment (participants) [Number]
United States	16 100%	20 100%	20 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Scale for the Assessment of Negative Symptoms (SANS) Total Score
Description	Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
Treatment Week 0	33.23 (6.91)	36.63 (10.09)	36.63 (10.61)
Treatment Week 2	30.07 (6.93)	35.22 (10.97)	35.05 (10.52)
Treatment Week 4	31.27 (7.53)	34.06 (10.26)	34.22 (9.61)
Treatment Week 6	31.40 (6.85)	33.22 (10.64)	33.47 (8.47)
Change from Week 0 at Week 2	-3.17 (4.20)	-1.41 (3.32)	-1.58 (4.84)
Change from Week 0 at Week 4	-1.97 (4.48)	-1.69 (3.46)	-1.47 (5.64)
Change from Week 0 at Week 6	-1.83 (3.74)	-2.53 (4.34)	-1.00 (4.41)

2. Primary Outcome

Title	Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week
Description	* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	14	15	16
Treatment Week 0	0.23 (0.92)	-0.22 (0.47)	0.21 (0.83)
Treatment Week 6	0.33 (1)	-0.05 (0.68)	0.18 (0.69)
Change	0.1 (0.37)	0.17 (0.44)	0.03 (0.41)

3. Secondary Outcome

Title	Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Description	Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
Treatment Week 0	2.94 (0.90)	2.91 (0.88)	2.44 (0.97)
Treatment Week 2	2.78 (0.77)	2.73 (0.74)	2.43 (0.93)
Treatment Week 4	2.85 (1.04)	2.74 (.084)	2.44 (0.94)
Treatment Week 6	2.88 (0.89)	2.74 (0.90)	2.41 (0.87)
Change from Week 0 at Week 2	-0.15 (0.32)	-0.18 (0.43)	-0.01 (0.57)
Change from Week 0 at Week 4	-0.09 (0.31)	-0.16 (0.50)	0.04 (0.43)
Change from Week 0 at Week 6	-0.05 (0.48)	-0.16 (0.69)	0.05 (0.46)

4. Secondary Outcome

Title	Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Description	Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
Treatment Week 0	2.42 (0.59)	2.60 (0.80)	2.66 (0.69)
Treatment Week 2	2.42 (0.64)	2.59 (0.86)	2.58 (0.66)
Treatment Week 4	2.27 (0.78)	2.46 (0.99)	2.60 (0.64)
Treatment Week 6	2.33 (0.49)	2.43 (0.98)	2.66 (0.60)
Change from Week 0 at Week 2	0.00 (0.37)	-0.01 (0.40)	-0.08 (0.51)
Change from Week 0 at Week 4	-0.15 (0.68)	-0.11 (.013)	0.01 (0.50)
Change from Week 0 at Week 6	-0.09 (0.38)	-0.14 (0.38)	0.12 (0.47)

5. Secondary Outcome

Title	Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Description	Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
Treatment Week 0	0.60 (0.61)	0.95 (0.65)	0.99 (0.69)
Treatment Week 2	0.44 (0.67)	0.89 (0.59)	0.89 (0.80)
Treatment Week 4	0.56 (0.70)	0.85 (0.50)	0.80 (0.61)
Treatment Week 6	0.56 (0.69)	0.78 (0.44)	0.69 (0.57)
Change from Week 0 at Week 2	-0.16 (0.42)	-0.05 (0.36)	-0.10 (0.35)
Change from Week 0 at Week 4	-0.04 (0.41)	-0.03 (0.37)	-0.17 (0.31)
Change from Week 0 at Week 6	-0.04 (0.46)	-0.10 (0.31)	-0.19 (0.31)

6. Secondary Outcome

Title	Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Description	Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
Treatment Week 0	1.67 (0.86)	1.96 (1.06)	2.21 (0.97)
Treatment Week 2	1.32 (0.90)	1.89 (1.10)	2.05 (1.12)
Treatment Week 4	1.52 (0.91)	1.79 (0.99)	1.94 (0.98)
Treatment Week 6	1.48 (0.96)	1.70 (1.05)	1.85 (0.94)
Change from Week 0 at Week 2	-0.35 (0.36)	-0.07 (0.36)	-0.16 (0.47)
Change from Week 0 at Week 4	-0.15 (0.44)	-0.09 (0.33)	-0.19 (0.60)
Change from Week 0 at Week 6	-0.19 (0.36)	-0.17 (0.40)	-0.19 (0.38)

7. Secondary Outcome

Title	Brief Psychiatric Rating Scale (BPRS) - Total Score
Description	The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data available for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Treatment Week 0	34.16 (5.66)	30.35 (6.66)	32.65 (7.09)
Treatment Week 2	34.00 (7.46)	28.95 (7.83)	31.75 (7.26)
Treatment Week 4	34.07 (6.15)	27.83 (6.88)	31.72 (7.25)
Treatment Week 6	34.33 (5.09)	27.67 (6.42)	32.18 (6.21)

8. Secondary Outcome

Title	Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Description	The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data available for the 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks	Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.	Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
Measure Participants	16	20	20
Treatment Week 0	9.34 (3.20)	7.30 (3.01)	8.18 (3.80)
Treatment Week 2	9.40 (3.79)	7.21 (3.61)	7.90 (3.86)
Treatment Week 4	9.87 (3.60)	7.00 (3.48)	8.06 (4.09)
Treatment Week 6	9.67 (2.87)	6.78 (3.21)	7.59 (4.35)

9. Secondary Outcome

Title	Calgary Depression Scale (CDS) - Total Score
Description	Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.
Time Frame	Every other week for 6 weeks

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
Treatment Week 0	2.37 (2.70)	0.84 (1.07)	1.59 (1.54)
Treatment Week 2	2.20 (2.54)	1.05 (1.65)	1.00 (1.29)
Treatment Week 4	2.13 (2.13)	0.67 (1.28)	0.94 (1.97)
Treatment Week 6	1.67 (2.47)	0.50 (0.71)	1.29 (1.45)

10. Secondary Outcome

Title	Arizona Sexual Experience Questionnaire (ASEX) Female
Description	Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Female participants who completed at least two weeks follow-up.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	2	6	3
Treatment Week 0	10.5 (0.7)	21.2 (7.6)	29.0 (1.7)
Treatment Week 6	13.5 (0.7)	19.2 (9.3)	30.0 (0)
Change	3.0 (0.0)	-2.0 (3.5)	0.0 (0.0)

11. Secondary Outcome

Title	Arizona Sexual Experience Questionnaire (ASEX) Male
Description	Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Male participants who completed at least two weeks follow-up.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	14	14	16
Treatment Week 0	16.5 (9.2)	18.1 (6.7)	20.8 (6.3)
Treatment Week 6	17.1 (8.5)	20.2 (7.5)	21.7 (7.7)
Change	1.5 (7.8)	1.6 (5.0)	0.8 (6.2)

12. Secondary Outcome

Title	Vital Signs - Diastolic Blood Pressure
Description	Mean diastolic blood pressure by treatment and follow-up week
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Treatment Week 0	78.8 (8.3)	76.6 (10.7)	78.3 (10.1)
Treatment Week 1	78.4 (9.0)	76.2 (8.9)	75.5 (10.8)
Treatment Week 2	76.7 (9.1)	77.5 (8.4)	79.7 (10.6)
Treatment Week 3	75.0 (10.6)	79.1 (6.9)	78.9 (8.1)
Treatment Week 4	73.9 (8.2)	75.1 (7.3)	73.7 (9.7)
Treatment Week 5	76.2 (8.8)	79.2 (8.4)	77.2 (10.9)
Treatment Week 6	74.4 (8.3)	80.7 (6.9)	76.0 (9.9)

13. Secondary Outcome

Title	Vital Signs - Systolic Blood Pressure
Description	Mean systolic blood pressure by treatment and follow-up week
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Treatment Week 0	128.4 (16.7)	123.4 (17.3)	132.3 (19.6)
Treatment Week 1	126.1 (16.9)	123.9 (15.0)	127.4 (22.1)
Treatment Week 2	121.9 (20.5)	123.7 (13.8)	136.2 (25.1)
Treatment Week 3	129.5 (21.1)	127.3 (19.0)	137.7 (17.0)
Treatment Week 4	124.8 (17.3)	123.8 (19.0)	129.9 (16.5)
Treatment Week 5	128.4 (20.5)	126.9 (20.1)	132.8 (19.5)
Treatment Week 6	124.0 (17.5)	129.6 (16.1)	134.5 (19.4)

14. Secondary Outcome

Title	Vital Signs - Weight
Description	Mean weight (kg) by treatment and follow-up week
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Treatment Week 0	96.5 (18.4)	96.2 (16.2)	96.4 (20.0)
Treatment Week 1	97.8 (19.1)	97.5 (16.0)	97.9 (18.9)
Treatment Week 2	98.0 (18.9)	97.5 (16.1)	98.3 (18.8)
Treatment Week 3	98.0 (18.9)	94.5 (13.8)	98.4 (19.5)
Treatment Week 4	100.0 (17.9)	95.5 (14.4)	100.3 (17.7)
Treatment Week 5	98.1 (18.6)	94.0 (14.6)	100.8 (17.7)
Treatment Week 6	97.6 (18.0)	95.1 (14.7)	97.9 (16.3)

15. Secondary Outcome

Title	Vital Signs - Pulse
Description	Mean sitting pulse (bpm) by treatment and follow-up week
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Treatment Week 0	81.2 (10.4)	86.0 (14.1)	85.2 (13.4)
Treatment Week 1	86.2 (18.8)	91.6 (14.9)	89.3 (16.7)
Treatment Week 2	82.7 (17.3)	91.3 (14.2)	87.3 (15.3)
Treatment Week 3	76.5 (11.5)	89.2 (15.6)	89.2 (13.8)
Treatment Week 4	79.6 (13.2)	88.6 (12.9)	83.7 (14.2)
Treatment Week 5	78.4 (13.2)	98.6 (28.1)	90.5 (16.0)
Treatment Week 6	76.1 (15.0)	85.2 (16.6)	84.7 (12.2)

16. Secondary Outcome

Title	Simpson-Angus Scale (SAS)
Description	SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.
Time Frame	Baseline, week 3, and week 6

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	19	19
No worsening (0)	80 500%	63.16 315.8%	78.95 394.8%
Worsening of 1	16.67 104.2%	10.53 52.7%	10.53 52.7%
Worsening of 2	6.67 41.7%	15.79 79%	0 0%
Worsening of 3	6.67 41.7%	5.26 26.3%	5.26 26.3%
Worsening of 4	0 0%	5.26 26.3%	0 0%
Worsening of 10	0 0%	0 0%	5.26 26.3%

17. Secondary Outcome

Title	Abnormal Involuntary Movement Scale (AIMS)
Description	AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

50 participants who completed the trial.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
No worsening (0)	86.67 541.7%	77.78 388.9%	76.47 382.4%
Worsening of 1	6.67 41.7%	16.67 83.4%	17.65 88.3%
Worsening of 2	6.67 41.7%	0 0%	0 0%
Worsening of 3	0 0%	0 0%	5.88 29.4%
Worsening of 5	0 0%	5.56 27.8%	0 0%

18. Secondary Outcome

Title	Electrocardiogram (EKG)
Description	Mean corrected QT interval (QTc) by study week and treatment.
Time Frame	Once during Evaluation and once at Treatment Week 6

Outcome Measure Data

Analysis Population Description

50 participants who completed the trial.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Evaluation Week 0	416.5 (23.1)	419.0 (26.6)	422.6 (25.5)
Treatment Week 6	415.7 (28.3)	408.1 (27.2)	423.8 (26.7)
Change	-2.9 (20.7)	-10.2 (18.3)	0.9 (20.3)

19. Secondary Outcome

Title	Barnes Akathisia Scale (BAS) - Global Score
Description	For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

50 participants who completed the trial.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
No worsening (0)	93.33 583.3%	100 500%	94.12 470.6%
Worsening of 1	6.67 41.7%	0 0%	5.88 29.4%

20. Secondary Outcome

Title	Blood Oxytocin Levels
Description	Blood Oxytocin Levels by Treatment and Visit
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.
Measure Participants	16	20	17
Treatment Week 0	18.22 (15.52)	13.76 (6.96)	14.69 (7.99)
Treatment Week 6	17.22 (17.02)	10.11 (3.42)	13.21 (9.32)
Change	-1.88 (14.09)	-2.99 (5.2)	-1.73 (3.95)

21. Secondary Outcome

Title	Laboratory Measures - ALT/SGPT
Description	Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data at Evaluation and Week 6.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	22.87 (8.68)	31.26 (22.93)	27.40 (19.78)
Treatment Week 6	20.67 (13.03)	28.90 (22.81)	27.74 (16.62)
Change	-2.15 (10.20)	-2.65 (6.14)	0.31 (8.10)

22. Secondary Outcome

Title	Laboratory Measures - AST/SGOT
Description	Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data at Evaluation and Week 6.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	19.87 (5.46)	22.68 (9.68)	22.50 (9.29)
Treatment Week 6	20.27 (8.94)	21.45 (10.16)	23.58 (9.26)
Change	-1.46 (4.20)	-1.53 (8.13)	1.00 (5.43)

23. Secondary Outcome

Title	Laboratory Measures - Alkaline Phosphatase
Description	Alkaline phosphatase blood level by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data at Evaluation at Week 6.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	83.47 (21.56)	83.42 (16.29)	86.40 (23.37)
Treatment Week 6	78.73 (31.09)	82.50 (20.50)	88.95 (29.67)
Change	-4.77 (15.81)	0.88 (10.29)	1.19 (10.97)

24. Secondary Outcome

Title	Laboratory Measures - Calcium
Description	Calcium blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data at Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	9.53 (0.33)	9.36 (0.31)	9.58 (0.41)
Treatment Week 6	9.57 (0.32)	9.23 (0.31)	9.54 (0.44)
Change	0.12 (0.33)	-0.16 (0.21)	-0.03 (0.36)

25. Secondary Outcome

Title	Laboratory Measures - Sodium
Description	Sodium blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data at Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	138.53 (2.29)	139.53 (2.89)	137.30 (4.28)
Treatment Week 6	138.53 (3.02)	139.15 (2.16)	137.47 (3.96)
Change	0.15 (1.63)	-0.53 (3.22)	0.31 (2.82)

26. Secondary Outcome

Title	Laboratory Measures - Potassium
Description	Potassium blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data at Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	4.20 (0.47)	4.14 (0.31)	4.17 (0.28)
Treatment Week 6	4.07 (0.32)	4.01 (0.27)	4.16 (0.39)
Change	-0.12 (0.43)	-0.15 (0.22)	0.00 (0.31)

27. Secondary Outcome

Title	Laboratory Measures - Chloride
Description	Chloride blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	100.60 (2.95)	102.79 (3.41)	100.15 (4.21)
Treatment Week 6	101.53 (3.54)	102.90 (2.63)	100.47 (3.78)
Change	0.62 (1.89)	-0.06 (2.70)	0.56 (2.80)

28. Secondary Outcome

Title	Laboratory Measures - CO2
Description	Carbon Dioxide (CO2) blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	23.47 (2.13)	22.42 (3.01)	23.40 (2.52)
Treatment Week 6	23.27 (2.09)	22.50 (2.33)	22.83 (2.15)
Change	-0.31 (2.21)	-0.06 (2.77)	-0.20 (1.52)

29. Secondary Outcome

Title	Laboratory Measures - Cholesterol
Description	Total cholesterol blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	14	15	15
Evaluation	159.18 (19.18)	166.07 (35.98)	179.60 (37.43)
Treatment Week 6	156.93 (22.57)	162.93 (22.57)	177.33 (36.76)
Change	1.50 (12.61)	-2.40 (15.87)	-11.44 (31.52)

30. Secondary Outcome

Title	Laboratory Measures - HDL
Description	High-density lipoprotein (HDL) blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant data from Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	13	14	14
Evaluation	44.09 (12.31)	45.50 (14.43)	41.14 (10.17)
Treatment Week 6	44.31 (14.07)	43.64 (11.62)	41.42 (10.75)
Change	-0.70 (6.31)	2.11 (3.69)	-1.67 (4.50)

31. Secondary Outcome

Title	Laboratory Measures - LDL
Description	Low-density lipoprotein (LDL) blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	13	14	14
Evaluation	90.36 (25.02)	91.25 (20.42)	105.79 (37.30)
Treatment Week 6	85.92 (28.72)	92.29 (19.51)	103.73 (33.32)
Change	-0.60 (11.58)	-1.38 (14.92)	-13.00 (26.79)

32. Secondary Outcome

Title	Laboratory Measures - Triglycerides
Description	Triglyceride blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	14	15	15
Evaluation	124.55 (60.32)	155.20 (118.82)	163.47 (102.54)
Treatment Week 6	124.79 (69.57)	142.29 (99.53)	162.17 (102.74)
Change	14.00 (40.14)	-39.30 (77.44)	1.22 (49.85)

33. Secondary Outcome

Title	Laboratory Measures - VLDL
Description	Very low density lipoprotein (VLDL) blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	12	13	12
Evaluation	24.73 (12.04)	22.00 (10.49)	33.17 (22.59)
Treatment Week 6	26.75 (13.93)	23.62 (9.50)	28.00 (14.04)
Change	2.80 (8.13)	-3.13 (6.31)	-0.43 (11.19)

34. Secondary Outcome

Title	Laboratory Measures - Glucose
Description	Glucose blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	18
Evaluation	108.07 (47.12)	98.61 (15.50)	103.00 (21.86)
Treatment Week 6	99.67 (19.53)	102.13 (18.13)	112.31 (33.36)
Change	-9.23 (30.91)	2.00 (20.64)	9.77 (16.51)

35. Secondary Outcome

Title	Laboratory Measures - Albumin
Description	Albumin blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	4.39 (0.24)	4.27 (0.31)	4.35 (0.30)
Treatment Week 6	4.38 (0.25)	4.23 (0.27)	4.37 (0.32)
Change	0.04 (0.23)	-0.03 (0.35)	0.03 (0.20)

36. Secondary Outcome

Title	Laboratory Measures - Globulin
Description	Globulin blood levels by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant lab data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	14	18	19
Evaluation	2.72 (0.40)	2.81 (0.42)	2.82 (0.37)
Treatment Week 6	2.58 (0.54)	2.66 (0.51)	2.78 (0.38)
Change	-0.15 (0.63)	-0.18 (0.38)	-0.09 (0.21)

37. Secondary Outcome

Title	Laboratory Measures - A/G Ratio
Description	Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant date for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	19
Evaluation	1.65 (0.29)	1.58 (0.27)	1.57 (0.26)
Treatment Week 6	1.71 (0.64)	1.62 (0.31)	1.60 (0.26)
Change	0.04 (0.22)	0.05 (0.18)	0.07 (0.12)

38. Secondary Outcome

Title	Laboratory Measures - Bilirubin
Description	Bilirubin blood level by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	19
Evaluation	0.45 (0.29)	0.35 (0.19)	0.40 (0.26)
Treatment Week 6	0.49 (0.24)	0.39 (0.24)	0.38 (0.15)
Change	0.03 (0.13)	0.05 (0.23)	0.03 (0.13)

39. Secondary Outcome

Title	Laboratory Measures - Protein
Description	Protein blood level by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	7.10 (0.32)	7.07 (0.41)	7.17 (0.40)
Treatment Week 6	7.14 (0.42)	6.92 (0.45)	7.15 (0.42)
Change	0.07 (0.30)	-0.13 (0.34)	-0.04 (0.37)

40. Secondary Outcome

Title	Laboratory Measures - BUN
Description	BUN blood level by treatment group and visit.
Time Frame	Once during evaluation and once at the end of 6 weeks of study treatment

Outcome Measure Data

Analysis Population Description

Available participant data for Evaluation and Week 6.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	20	20
Evaluation	12.80 (4.92)	10.74 (3.18)	11.95 (4.10)
Treatment Week 6	12.73 (4.85)	11.55 (3.41)	12.00 (4.76)
Change	0.15 (2.82)	1.06 (3.07)	-0.06 (3.38)

41. Secondary Outcome

Title	Side Effect Checklist (SEC) - Abdominal Pain
Description	Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	12.5 78.1%	5.0 25%	10.0 50%

42. Secondary Outcome

Title	Side Effect Checklist (SEC) - Anorexia
Description	Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	10.0 50%	15.0 75%

43. Secondary Outcome

Title	Side Effect Checklist (SEC) - Bruising Easily
Description	Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	0.0 0%	10.0 50%	0.0 0%

44. Secondary Outcome

Title	Side Effect Checklist (SEC) - Constipation
Description	Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	0.0 0%	0.0 0%	0.0 0%

45. Secondary Outcome

Title	Side Effect Checklist (SEC) - Diarrhea
Description	Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	30.0 150%	5.0 25%

46. Secondary Outcome

Title	Side Effect Checklist (SEC) - Dizziness
Description	Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	30.0 150%	5.0 25%

47. Secondary Outcome

Title	Side Effect Checklist (SEC) - Dry Eye
Description	Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "dry eye" data.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Number [percentage of participants]	6.7 41.9%	0.0 0%	5.9 29.5%

48. Secondary Outcome

Title	Side Effect Checklist (SEC) - Dry Mouth
Description	Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	5.0 25%	10.0 50%

49. Secondary Outcome

Title	Side Effect Checklist (SEC) - Enuresis
Description	Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	25.0 156.3%	5.0 25%	0.0 0%

50. Secondary Outcome

Title	Side Effect Checklist (SEC) - Excessive Tearing of the Eye
Description	Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "excessive tearing of the eye" data.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Number [percentage of participants]	6.7 41.9%	5.6 28%	5.9 29.5%

51. Secondary Outcome

Title	Side Effect Checklist (SEC) - Fever
Description	Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	0.0 0%	5.0 25%	0.0 0%

52. Secondary Outcome

Title	Side Effect Checklist (SEC) - Headache
Description	Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	12.5 78.1%	25.0 125%	15.0 75%

53. Secondary Outcome

Title	Side Effect Checklist (SEC) - Hyperhydrosis
Description	Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "Hyperhydrosis" data.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Number [percentage of participants]	0.0 0%	0.0 0%	0.0 0%

54. Secondary Outcome

Title	Side Effect Checklist (SEC) - Hypersalivation
Description	Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	15.0 75%	25.0 125%

55. Secondary Outcome

Title	Side Effect Checklist (SEC) - Insomnia
Description	Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	10.0 50%	5.0 25%

56. Secondary Outcome

Title	Side Effect Checklist (SEC) - Malaise
Description	Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	0.0 0%	10.0 50%

57. Secondary Outcome

Title	Side Effect Checklist (SEC) - Mucosal Ulceration
Description	Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	6.3 39.4%	5.0 25%	0.0 0%

58. Secondary Outcome

Title	Side Effect Checklist (SEC) - Nasal Irritation
Description	Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "nasal irritation" data.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Number [percentage of participants]	33.3 208.1%	16.7 83.5%	23.5 117.5%

59. Secondary Outcome

Title	Side Effect Checklist (SEC) - Nausea
Description	Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	15.0 75%	5.0 25%

60. Secondary Outcome

Title	Side Effect Checklist (SEC) - Rash
Description	Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	12.5 78.1%	10.0 50%	10.0 50%

61. Secondary Outcome

Title	Side Effect Checklist (SEC) - Restlessness
Description	Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	10.0 50%	15.0 75%

62. Secondary Outcome

Title	Side Effect Checklist (SEC) - Sedation
Description	Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	12.5 78.1%	15.0 75%	10.0 50%

63. Secondary Outcome

Title	Side Effect Checklist (SEC) - Sore Throat
Description	Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	6.3 39.4%	10.0 50%	5.0 25%

64. Secondary Outcome

Title	Side Effect Checklist (SEC) - Stiffness
Description	Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	6.3 39.4%	10.0 50%	10.0 50%

65. Secondary Outcome

Title	Side Effect Checklist (SEC) - Tinnitus
Description	Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	19
Number [percentage of participants]	0.0 0%	0.0 0%	10.5 52.5%

66. Secondary Outcome

Title	Side Effect Checklist (SEC) - Tremor
Description	Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	6.3 39.4%	15.0 75%	10.0 50%

67. Secondary Outcome

Title	Side Effect Checklist (SEC) - Urticaria
Description	Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	15.0 75%	15.0 75%

68. Secondary Outcome

Title	Side Effect Checklist (SEC) - Uterine Contractions
Description	Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Female participants

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	2	6	3
Number [percentage of participants]	0.0 0%	0.0 0%	0.0 0%

69. Secondary Outcome

Title	Side Effect Checklist (SEC) - Vomiting
Description	Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	12.5 78.1%	5.0 25%	10.0 50%

70. Secondary Outcome

Title	Side Effect Checklist (SEC) - Weight Loss
Description	Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	16	20	20
Number [percentage of participants]	18.8 117.5%	5.0 25%	25.0 125%

71. Secondary Outcome

Title	Side Effect Checklist (SEC) - Wheezing
Description	Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group.
Time Frame	Weekly for 6 weeks

Outcome Measure Data

Analysis Population Description

Safety data for 56 participants exposed to study treatment minus 6 participants with missing "wheezing" data.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Number [percentage of participants]	13.3 83.1%	5.6 28%	11.8 59%

72. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Composite Score
Description	MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin/Placebo-galantamine	2: Galantamine/Placebo-oxytocin	3: Placebo-galantamine /Placebo-oxytocin
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	16	15
Treatment Week 0	25.9 (13.0)	24.5 (9.7)	28.2 (9.6)
Treatment Week 6	28.2 (14.1)	26.2 (11.1)	28.9 (11.8)
Change	2.3 (3.9)	1.7 (4.0)	0.7 (8.0)

73. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Attention Vigilance
Description	MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. .
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	17	17
Treatment Week 0	36.9 (8.8)	33.5 (14.5)	37.2 (10.9)
Treatment Week 6	39.5 (11.3)	34.5 (13.6)	35.1 (12.7)
Change	2.6 (5.8)	1.1 (6.9)	-2.1 (6.9)

74. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Processing Speed
Description	MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Treatment Week 0	33.5 (13.1)	31.9 (11.7)	34.0 (10.9)
Treatment Week 6	34.2 (11.6)	35.4 (8.6)	35.6 (12.7)
Change	0.7 (4.3)	3.5 (5.6)	1.6 (7.3)

75. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving
Description	MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Treatment Week 0	39.7 (10.8)	39.3 (6.8)	41.4 (8.4)
Treatment Week 6	40.7 (9.4)	42.9 (8.3)	41.7 (9.7)
Change	1.0 (8.1)	3.7 (5.1)	0.3 (10.1)

76. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Social Cognition
Description	MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	17	15
Treatment Week 0	31.7 (9.7)	32.8 (10.4)	30.4 (10.1)
Treatment Week 6	32.5 (13.0)	29.6 (10.0)	32.8 (10.9)
Change	0.8 (7.6)	-3.2 (4.6)	2.4 (7.3)

77. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Verbal Learning
Description	MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Treatment Week 0	36.3 (8.5)	33.4 (5.0)	36.5 (8.2)
Treatment Week 6	38.7 (9.9)	35.8 (7.7)	36.4 (4.4)
Change	2.5 (5.4)	2.4 (5.8)	-0.1 (7.6)

78. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Visual Learning
Description	MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Treatment Week 0	33.8 (14.3)	37.2 (10.8)	35.1 (9.4)
Treatment Week 6	36.2 (16.6)	33.7 (10.0)	34.2 (10.3)
Change	2.4 (6.2)	-3.4 (8.3)	-0.9 (7.2)

79. Secondary Outcome

Title	Neurocognitive Assessment Battery (MCCB) - Working Memory
Description	MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame	Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).

Outcome Measure Data

Analysis Population Description

Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	18	17
Treatment Week 0	34.7 (10.7)	33.7 (9.6)	35.3 (11.0)
Treatment Week 6	34.8 (11.1)	34.7 (10.4)	38.1 (11.7)
Change	0.1 (6.5)	0.9 (7.7)	2.8 (6.4)

80. Secondary Outcome

Title	Positive and Negative Affect Schedule (PANAS) - Negative
Description	Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	17	17
Treatment Week 0	20.5 (7.8)	18.2 (7.0)	20.2 (8.6)
Treatment Week 6	18.8 (7.7)	18.0 (5.6)	18.9 (8.2)
Change from Week 0 at Week 6	-1.7 (5.7)	-0.2 (6.8)	-1.3 (5.6)

81. Secondary Outcome

Title	Positive and Negative Affect Schedule (PANAS) - Positive
Description	Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	17	17
Treatment Week 0	38.1 (8.6)	37.0 (12.3)	42.5 (8.9)
Treatment Week 6	38.5 (12.8)	39.5 (12.3)	40.8 (9.6)
Change from Week 0 at Week 6	0.4 (10.8)	2.5 (11.4)	-1.6 (11.2)

82. Secondary Outcome

Title	Reactions to Partner
Description	Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being "completely agree" and 5 being "completely disagree". The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	17	17
Treatment Week 0	13.7 (4.2)	14.4 (5.6)	12.5 (4.2)
Treatment Week 6	13.7 (3.1)	13.9 (3.7)	12.5 (3.5)
Change from Week 0 at Week 6	0.0 (3.5)	-0.4 (4.0)	0.0 (3.7)

83. Secondary Outcome

Title	Willingness to Interact
Description	Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being "definitely willing" and 5 being "definitely unwilling". The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.
Time Frame	Treatment Week 0 and Week 6

Outcome Measure Data

Analysis Population Description

Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.

Arm/Group Title	1: Oxytocin	2: Galantamine	3: Placebo
Arm/Group Description	Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine	Subjects randomized to galantamine will receive galantamine and placebo-oxytocin	Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Measure Participants	15	17	17
Treatment Week 0	23.67 (4.13)	23.18 (4.22)	24.41 (4.33)
Treatment Week 6	24.47 (3.31)	24.24 (4.34)	25.00 (4.29)
Change from Week 0 at Week 6	0.80 (3.82)	1.06 (3.60)	0.59 (4.02)

Adverse Events

Arm/Group Title	1: Oxytocin		2: Galantamine		3: Placebo
Arm/Group Description	Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks		Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.		Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
All Cause Mortality
	1: Oxytocin		2: Galantamine		3: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	1: Oxytocin		2: Galantamine		3: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		1/20 (5%)		0/21 (0%)
Respiratory, thoracic and mediastinal disorders
hospitalization due to unrelated pneumonia	0/17 (0%)		1/20 (5%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	1: Oxytocin		2: Galantamine		3: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/17 (23.5%)		1/20 (5%)		0/21 (0%)
Renal and urinary disorders
Enuresis	4/17 (23.5%)		1/20 (5%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.