D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00237809
• Collaborator: National Alliance for Research on Schizophrenia and Depression (Other), Donaghue Medical Research Foundation (Other)
• Enrollment: 104
• Locations: 2
• Arms: 4
• Duration (Months): 120
• Patients Per Site: 52
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: D-serine; Behavioral: Cognitive Retraining (CRT); Drug: Placebo; Behavioral: Cognitive Retraining Placebo	Phase 3

Detailed Description

Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug and control CRT D-serine/control	Drug: D-serine; D-serine (30 mg/kg); Behavioral: Cognitive Retraining Placebo; Cognitive retraining therapy (CRT) control
Experimental: Drug and CRT D-serine/cog rehab	Drug: D-serine; D-serine (30 mg/kg); Behavioral: Cognitive Retraining (CRT); Cognitive retraining therapy (CRT)
Experimental: Placebo Drug and Placebo CRT Placebo/control	Drug: Placebo; Placebo D-serine Drug; Behavioral: Cognitive Retraining Placebo; Cognitive retraining therapy (CRT) control
Experimental: Placebo Drug and CRT Placebo/cog rehab	Behavioral: Cognitive Retraining (CRT); Cognitive retraining therapy (CRT); Drug: Placebo; Placebo D-serine Drug

Outcome Measures

Primary Outcome Measures

1. Wisconsin Card Sorting Test (WCST) [12 weeks]

   The WCST allows the clinician to speculate to the following "frontal" lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability.

2. Hopkins Verbal Learning Test [12 weeks]

   The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.

3. Spatial Span- Total Score [12 weeks]

   The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.

4. Positive and Negative Syndrome Scale (PANSS) [12 weeks]

   The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.

Secondary Outcome Measures

1. Heinrichs-Carpenter Quality of Life Scale [12 weeks]

   The Heinrichs-Carpenter Quality of Life Scale is a testing device. It has a range of possible scores, 0-126 used to evaluate social functioning & behavior in patients with schizophrenia-lower scores represent poorer mental health.

2. Simpson-Angus Neurological Rating Scale [12 weeks]

   Simpson-Angus Scale (SAS) is a 10-item rating scale that has been used widely for assessment in both clinical practice and research settings. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The highest possible score is 40.

3. UCSD Performance-Based Skills Assessment (UPSA) [12 weeks]

   The UCSD Performance-Based Skills Assessment (UPSA) is a role-play test designed to evaluate a person's functional capacity in two selected areas of basic living skills. These areas include Finance and Communication. Subjects being tested utilize props to demonstrate how they perform everyday activities and are assessed on their actual performance. The higher the score, the better the performance of an individual. The scores range from 0 to 100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

• Pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Mental Health Center	New Haven	Connecticut	United States	06508
2	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University
• National Alliance for Research on Schizophrenia and Depression
• Donaghue Medical Research Foundation

Investigators

• Principal Investigator: Deepak C D'Souza, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Heresco-Levy U, Javitt DC, Ebstein R, Vass A, Lichtenberg P, Bar G, Catinari S, Ermilov M. D-serine efficacy as add-on pharmacotherapy to risperidone and olanzapine for treatment-refractory schizophrenia. Biol Psychiatry. 2005 Mar 15;57(6):577-85.
• Tsai G, Yang P, Chung LC, Lange N, Coyle JT. D-serine added to antipsychotics for the treatment of schizophrenia. Biol Psychiatry. 1998 Dec 1;44(11):1081-9.
• Tsai GE, Yang P, Chung LC, Tsai IC, Tsai CW, Coyle JT. D-serine added to clozapine for the treatment of schizophrenia. Am J Psychiatry. 1999 Nov;156(11):1822-5.

• Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
• ClinicalTrials.gov Identifier: NCT00237809
• Other Study ID Numbers: 23594; DF01-015
• First Posted: Oct 12, 2005
• Last Update Posted: May 10, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Cognition Disorders; Cognitive Dysfunction

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled between 2003 and 2008, with enrollment of subjects in India starting later (2005) and ending in 2008.
Pre-assignment Detail	132 subjects were screened for eligibility. After screening, eligible subjects were randomized to receive: D-serine+CRT, placebo D-serine+CRT, D-serine + control CRT, or placebo D-serine + control CRT. Randomization was stratified by screening performance IQ. Separate randomization schedules (block size= 4) were generated within IQ stratum.

Arm/Group Title	D-serine Drug /CRT Placebo	Placebo Drug /CRT	D-serine Drug/CRT	Placebo Drug/ Placebo CRT
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control
Period Title: Overall Study
STARTED	27	27	24	26
COMPLETED	16	17	15	17
NOT COMPLETED	11	10	9	9

Baseline Characteristics

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control	Total
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : Cog rehab	Total of all reporting groups
Overall Participants	27	27	24	26	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.7500 (8.01889)	34.4762 (8.76139)	36.3158 (9.16547)	34.4545 (9.36420)	35.21 (8.72)
Sex: Female, Male (Count of Participants)
Female	9 33.3%	5 18.5%	5 20.8%	7 26.9%	26 25%
Male	18 66.7%	22 81.5%	19 79.2%	19 73.1%	78 75%

Outcome Measures

1. Primary Outcome

Title	Wisconsin Card Sorting Test (WCST)
Description	The WCST allows the clinician to speculate to the following "frontal" lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [percentage of correct responses]	38.43 (24.07)	35.79 (21.57)	43.14 (27.06)	39.57 (22.31)

2. Primary Outcome

Title	Hopkins Verbal Learning Test
Description	The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [units on a scale]	20.74 (5.25)	19.80 (5.94)	20.42 (7.51)	21.45 (5.85)

3. Primary Outcome

Title	Spatial Span- Total Score
Description	The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [units on a scale]	13.59 (4.18)	13.88 (4.20)	13.21 (3.23)	13.58 (4.07)

4. Primary Outcome

Title	Positive and Negative Syndrome Scale (PANSS)
Description	The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [units on a scale]	53.30 (13.58)	52.01 (13.34)	53.79 (12.76)	53.96 (12.43)

5. Secondary Outcome

Title	Heinrichs-Carpenter Quality of Life Scale
Description	The Heinrichs-Carpenter Quality of Life Scale is a testing device. It has a range of possible scores, 0-126 used to evaluate social functioning & behavior in patients with schizophrenia-lower scores represent poorer mental health.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [units on a scale]	67.26 (20.04)	68.30 (25.59)	63.25 (24.15)	63.92 (19.53)

6. Secondary Outcome

Title	Simpson-Angus Neurological Rating Scale
Description	Simpson-Angus Scale (SAS) is a 10-item rating scale that has been used widely for assessment in both clinical practice and research settings. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The highest possible score is 40.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [units on a scale]	1.41 (2.53)	0.72 (1.73)	1.04 (1.27)	1.81 (2.25)

7. Secondary Outcome

Title	UCSD Performance-Based Skills Assessment (UPSA)
Description	The UCSD Performance-Based Skills Assessment (UPSA) is a role-play test designed to evaluate a person's functional capacity in two selected areas of basic living skills. These areas include Finance and Communication. Subjects being tested utilize props to demonstrate how they perform everyday activities and are assessed on their actual performance. The higher the score, the better the performance of an individual. The scores range from 0 to 100.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-serine/Control	Placebo/Cog Rehab	D-serine/Cog Rehab	Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)	Placebo/cog rehab Cognitive retraining : Cog rehab	D-serine/cog rehab D-serine : D-serine (30 mg/kg)	Placebo/control Cognitive retraining : video
Measure Participants	27	27	24	26
Mean (Standard Deviation) [units on a scale]	34.19 (9.41)	32.80 (10.98)	32.60 (13.82)	31.39 (10.01)

Adverse Events

Time Frame	Adverse events (serious and other) are reported overall at the month time frame.
Arm/Group Title	D-serine/Control		Placebo/Cog Rehab		D-serine/Cog Rehab		Placebo/Control
Arm/Group Description	D-serine/control D-serine : D-serine (30 mg/kg)		Placebo/cog rehab Cognitive retraining : Cog rehab		D-serine/cog rehab D-serine : D-serine (30 mg/kg)		Placebo/control Cognitive retraining : video
All Cause Mortality
	D-serine/Control		Placebo/Cog Rehab		D-serine/Cog Rehab		Placebo/Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	D-serine/Control		Placebo/Cog Rehab		D-serine/Cog Rehab		Placebo/Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)		0/24 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	D-serine/Control		Placebo/Cog Rehab		D-serine/Cog Rehab		Placebo/Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/27 (51.9%)		14/27 (51.9%)		12/24 (50%)		18/26 (69.2%)
Eye disorders
Accommodation Distance	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Photosensitivity	0/27 (0%)	0	0/27 (0%)	0	1/24 (4.2%)	1	1/26 (3.8%)	5
Increased Pigmentation	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Gastrointestinal disorders
Increased Salivation	2/27 (7.4%)	2	1/27 (3.7%)	1	2/24 (8.3%)	2	2/26 (7.7%)	2
Reduced Salivation	1/27 (3.7%)	1	1/27 (3.7%)	3	1/24 (4.2%)	1	2/26 (7.7%)	5
Nausea	1/27 (3.7%)	1	0/27 (0%)	0	1/24 (4.2%)	1	2/26 (7.7%)	3
Diarrhea	1/27 (3.7%)	1	2/27 (7.4%)	3	2/24 (8.3%)	2	4/26 (15.4%)	4
Constipation	3/27 (11.1%)	3	0/27 (0%)	0	1/24 (4.2%)	1	1/26 (3.8%)	2
General disorders
Dizziness	0/27 (0%)	0	2/27 (7.4%)	3	2/24 (8.3%)	3	4/26 (15.4%)	6
Polyps / Tachycardia	0/27 (0%)	0	1/27 (3.7%)	1	1/24 (4.2%)	1	1/26 (3.8%)	2
Increased Sweat	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Rash	0/27 (0%)	0	0/27 (0%)	0	1/24 (4.2%)	2	0/26 (0%)	0
Pruritus	0/27 (0%)	0	0/27 (0%)	0	1/24 (4.2%)	1	0/26 (0%)	0
Tension Headache	1/27 (3.7%)	1	0/27 (0%)	0	0/24 (0%)	0	1/26 (3.8%)	1
Migraine Headache	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Physical Dependence	2/27 (7.4%)	4	1/27 (3.7%)	4	0/24 (0%)	0	3/26 (11.5%)	5
Psychological Dependence	1/27 (3.7%)	1	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Other Headache	0/27 (0%)	0	0/27 (0%)	0	1/24 (4.2%)	1	0/26 (0%)	0
Metabolism and nutrition disorders
Weight Increase	2/27 (7.4%)	2	4/27 (14.8%)	6	3/24 (12.5%)	5	8/26 (30.8%)	12
Weight Decrease	1/27 (3.7%)	1	1/27 (3.7%)	1	0/24 (0%)	0	0/26 (0%)	0
Nervous system disorders
Dystonia	2/27 (7.4%)	2	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Rigidity	4/27 (14.8%)	8	0/27 (0%)	0	3/24 (12.5%)	4	7/26 (26.9%)	12
Hypokinesia	2/27 (7.4%)	5	1/27 (3.7%)	1	1/24 (4.2%)	1	2/26 (7.7%)	5
Hyperkinesia	5/27 (18.5%)	11	1/27 (3.7%)	5	2/24 (8.3%)	4	5/26 (19.2%)	10
Tremor	2/27 (7.4%)	2	5/27 (18.5%)	6	3/24 (12.5%)	5	5/26 (19.2%)	14
Akathesia	2/27 (7.4%)	3	2/27 (7.4%)	3	2/24 (8.3%)	3	3/26 (11.5%)	6
Epileptic Seizure	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Paraesthesias	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Psychiatric disorders
Concentration Difficulty	2/27 (7.4%)	2	2/27 (7.4%)	2	2/24 (8.3%)	2	3/26 (11.5%)	3
Increased Fatigue	4/27 (14.8%)	5	3/27 (11.1%)	3	1/24 (4.2%)	1	4/26 (15.4%)	4
Sleepiness	6/27 (22.2%)	15	7/27 (25.9%)	8	6/24 (25%)	12	9/26 (34.6%)	20
Failed Memory	2/27 (7.4%)	2	0/27 (0%)	0	2/24 (8.3%)	3	4/26 (15.4%)	4
Depression	3/27 (11.1%)	3	2/27 (7.4%)	4	1/24 (4.2%)	2	3/26 (11.5%)	7
Tension	2/27 (7.4%)	2	3/27 (11.1%)	3	2/24 (8.3%)	4	3/26 (11.5%)	6
Increased Sleep	8/27 (29.6%)	13	5/27 (18.5%)	6	3/24 (12.5%)	6	6/26 (23.1%)	9
Reduced Sleep	2/27 (7.4%)	2	2/27 (7.4%)	3	3/24 (12.5%)	4	1/26 (3.8%)	1
Increased Dreams	1/27 (3.7%)	1	2/27 (7.4%)	2	0/24 (0%)	0	4/26 (15.4%)	5
Emotional Indifference	0/27 (0%)	0	2/27 (7.4%)	2	1/24 (4.2%)	1	1/26 (3.8%)	2
Renal and urinary disorders
Micturition Distance	0/27 (0%)	0	1/27 (3.7%)	1	0/24 (0%)	0	0/26 (0%)	0
Polyuria	2/27 (7.4%)	2	1/27 (3.7%)	1	0/24 (0%)	0	2/26 (7.7%)	3
Reproductive system and breast disorders
Menorrhagia	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Amenorrhoea	3/27 (11.1%)	8	2/27 (7.4%)	20	1/24 (4.2%)	3	0/26 (0%)	0
Galactorrhoea	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Gynaecomastia	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Increased Sexual Desire	0/27 (0%)	0	0/27 (0%)	0	0/24 (0%)	0	0/26 (0%)	0
Diminished Sexual Desire	3/27 (11.1%)	5	1/27 (3.7%)	2	0/24 (0%)	0	2/26 (7.7%)	8
Sexual Dysfunction	3/27 (11.1%)	5	0/27 (0%)	0	0/24 (0%)	0	3/26 (11.5%)	11

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.