D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
Study Details
Study Description
Brief Summary
This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to testing efficacy, this trial will characterize DCS effects in terms of time course and persistence of response and will examine DCS effects on memory consolidation and cognitive flexibility as possible mediators of DCS enhancement of CBT for delusions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study consists of a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to testing efficacy, this trial will characterize DCS effects in terms of time course and persistence of response and will examine DCS effects on memory consolidation and cognitive flexibility as possible mediators of DCS enhancement of CBT for delusions. This study will be conducted by the Schizophrenia Research Group of the NYU Langone Medical Center at One Park Avenue 8th Floor and the Psychiatry Outpatient Clinic of Bellevue Hospital located in New York, NY.
Upon signing consent, patients will undergo screening procedures to assess eligibility. A diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder will be determined by the Structured Clinical Interview for DSM IV (SCID) completed by a research clinician using all available clinical data and will be confirmed by consensus diagnosis. A comprehensive medical history and physical exam, including measurement of vital signs, will be performed. A psychiatric history, including diagnosis, treatment history, current medications, and substance use will also be performed. A research assistant will complete the demographics and administer the Scale for Assessment of Positive Symptoms-Delusions (SAPS-D).
At screening only, a fasting blood sample will be obtained to perform routine laboratory tests including electrolytes, BUN, creatinine, liver function tests, fasting glucose, calcium, phosphate, magnesium, albumin and CBC with differential. Urinalysis will be performed to identify unstable medical illness. A urine toxicology screen will be performed and a urine pregnancy test will be done for women of child bearing potential.
Subjects who meet study eligibility criteria will complete the Logical Memory Test portion of the Weschler Memory Scale-III (WMS-III) one week before the baseline visit.
The baseline visit will include the following assessments: SAPS-D, Psychotic Symptom Rating Scales (PSYRATS), Brief Psychiatric Rating Scale (BPRS), Scale for the Assessment of Negative Symptoms (SANS), Calgary Depression Rating Scale (CDRS), Clinical Global Impression (CGI), Heinrich's Quality of Life Scale (Heinrich's QOL), Peter's Delusion Inventory (PDI), Birchwood Insight Scale (BIS), Drug and Alcohol Questionnaire (DAUQ), and the Pittsburg Sleep Quality Index (PSQI) . At the baseline visit the following cognitive assessments will be administered: the Logical Memory Test of the WMS-III, The Wisconsin Card Sort Test (WCST), Verbal Fluency Test (VFT), and the MATRICS Consensus Cognitive Battery (MCCB).
The clinical battery of assessments including the PSYRATS, BPRS, SANS, CDRS, CGI, and Heinrich's QOL will be performed on weeks 4, 8, 12, 24, and 36. The delusions section only of the PSYRATS will be performed on weeks 2, 3, 6, and 10. The Logical Memory Test will be administered on screening visit 2, baseline, week 3, and week 4. The Alternative Beliefs Exercise will occur on weeks 3, 4, and 12. The WCST and VFT will be given to participants at the baseline visit and week 12. Side effects will be assessed using the Systematic Assessment for Treatment Emergent Events (SAFTEE)on weeks 3, 4, 8, and 12.
Beginning at week 1, participants will engage in hour long sessions of Cognitive Behavioral Therapy for delusions. This treatment course will continue weekly from week 1 until week 12 (12 sessions).
For the first two sessions of CBT during weeks 1 and 2, both the experimental and the placebo group will receive a placebo pill by mouth one hour before CBT sessions. Starting week 2, the placebo and experimental groups will receive their respective drugs one hour before CBT sessions from weeks 3-12 (placebo by mouth to placebo group, 50 mg D-cycloserine by mouth to experimental group).
The primary outcome of interest in the study is the change in PSYRATS Delusions Subscale total score compared to placebo from baseline to week 12. Secondary outcome measures include changes as defined by a 20% reduction in PSYRATS Delusions Subscale total score from baseline after 2 weeks of DCS treatment versus placebo as well changes as defined by maintenance of a 20% or greater reduction in the PSYRATS Delusions Subscale total score from baseline at a 3 and 6 month follow up as compared to placebo.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). |
Other: Placebo
Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.
Other Names:
Behavioral: Cognitive Behavioral Therapy
Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Other Names:
|
| Experimental: D-Cycloserine Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). |
Drug: D-Cycloserine
Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.
Other Names:
Behavioral: Cognitive Behavioral Therapy
Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D) [Baseline to Week 12]
The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Secondary Outcome Measures
- Change in Logical Memory Test-WMS-III [7 days after Baseline, and 7 days after Screening visit 2]
The Logical Memory Test of the Wechsler Memory Scale is a measure of verbal declarative memory. We are using it to evaluate memory consolidation by analyzing the number of thematic elements recalled after a delay of 7 days. Participants are read two different stories-one at Screening visit #2 and one at Baseline. They are asked to recall specific items and narrative themes after 7 days. Scores range from 0-7, 7 indicating perfect thematic recall, and 0 indicating no thematic elements were remembered and worse thematic recall. We hypothesize that improved memory consolidation (assessed with the Logical Memory Test) tested 7 days after the first dose of D-cycloserine will predict improvement of delusional scores measured by the PSYRATS-D. The reported outcome (change in Logical Memory Test score) was calculated by subtracting the screening visit 2 score from the baseline score for each participant.
- Change in Alternate Beliefs Exercise (ABE) [Week 3 to Week 4]
The Alternate Belief Exercise is a measurement of cognitive flexibility. The scores range from 0-21, and a higher score indicates an increased number of alternative beliefs reported. This outcome measurement reports the change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks. Thus a higher score in this outcome measurement indicates a greater number of alternative beliefs reported at week 4 as compared to week 3. This implies greater cognitive flexibility at week 4 as compared to week 3 directly after drug administration.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-68
-
Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder
-
Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic naive for lifetime
-
Willing to participate in CBT
-
Sufficient proficiency in English to complete assessments
-
Score of at least 3 on the SAPS at two assessments, four weeks apart
Exclusion Criteria:
-
Current treatment with clozapine
-
SSRI treatment
-
Active alcohol or other substance abuse within six weeks
-
Unstable medical illness
-
Pregnant or nursing
-
Anemia
-
Renal insufficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheppard Pratt | Baltimore | Maryland | United States | 21204 |
| 2 | New York Langone Medical Center/Bellevue Hospital | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Donald C Goff, MD, NYU Langone Health
Study Documents (Full-Text)
More Information
Publications
None provided.- 12-02991
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | As the screening period lasts up to four weeks before the baseline visit and participants are not randomized until week 3, 59 participants were either screen failures or dropped out before randomization to treatment group. |
| Arm/Group Title | Placebo | D-Cycloserine |
|---|---|---|
| Arm/Group Description | Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. |
| Period Title: Overall Study | ||
| STARTED | 28 | 30 |
| Baseline (Week 1) | 28 | 30 |
| Randomization (Week 3) | 28 | 30 |
| Completed Week 12 | 22 | 22 |
| COMPLETED | 21 | 19 |
| NOT COMPLETED | 7 | 11 |
Baseline Characteristics
| Arm/Group Title | Placebo | D-Cycloserine | Total |
|---|---|---|---|
| Arm/Group Description | Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Total of all reporting groups |
| Overall Participants | 28 | 30 | 58 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
45.55
(11.97)
|
44.60
(13.26)
|
44.82
(12.57)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12
42.9%
|
11
36.7%
|
23
39.7%
|
| Male |
16
57.1%
|
19
63.3%
|
35
60.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
10.7%
|
2
6.7%
|
5
8.6%
|
| Not Hispanic or Latino |
25
89.3%
|
28
93.3%
|
53
91.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
3.3%
|
1
1.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
12
42.9%
|
9
30%
|
21
36.2%
|
| White |
10
35.7%
|
14
46.7%
|
24
41.4%
|
| More than one race |
3
10.7%
|
1
3.3%
|
4
6.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D) |
|---|---|
| Description | The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24. |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| For week 12 values, only those who completed the week 12 assessments are included in the analysis. |
| Arm/Group Title | Placebo | D-Cycloserine |
|---|---|---|
| Arm/Group Description | Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. |
| Measure Participants | 28 | 30 |
| Baseline PSYRATS Delusion Subscale Total |
14.26
(5.30)
|
11.83
(5.58)
|
| Week 12 PSYRATS Delusion Subscale Total |
12.18
(3.79)
|
11.91
(5.26)
|
| Title | Change in Logical Memory Test-WMS-III |
|---|---|
| Description | The Logical Memory Test of the Wechsler Memory Scale is a measure of verbal declarative memory. We are using it to evaluate memory consolidation by analyzing the number of thematic elements recalled after a delay of 7 days. Participants are read two different stories-one at Screening visit #2 and one at Baseline. They are asked to recall specific items and narrative themes after 7 days. Scores range from 0-7, 7 indicating perfect thematic recall, and 0 indicating no thematic elements were remembered and worse thematic recall. We hypothesize that improved memory consolidation (assessed with the Logical Memory Test) tested 7 days after the first dose of D-cycloserine will predict improvement of delusional scores measured by the PSYRATS-D. The reported outcome (change in Logical Memory Test score) was calculated by subtracting the screening visit 2 score from the baseline score for each participant. |
| Time Frame | 7 days after Baseline, and 7 days after Screening visit 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Reported summary statistics are for participants randomized at three weeks. One randomized participant is excluded from these results as they did not complete the Logical Memory Test at the baseline visit. |
| Arm/Group Title | Placebo | D-Cycloserine |
|---|---|---|
| Arm/Group Description | Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. |
| Measure Participants | 27 | 30 |
| Mean (Standard Deviation) [Change in a score] |
-0.96
(1.32)
|
-1.03
(1.30)
|
| Title | Change in Alternate Beliefs Exercise (ABE) |
|---|---|
| Description | The Alternate Belief Exercise is a measurement of cognitive flexibility. The scores range from 0-21, and a higher score indicates an increased number of alternative beliefs reported. This outcome measurement reports the change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks. Thus a higher score in this outcome measurement indicates a greater number of alternative beliefs reported at week 4 as compared to week 3. This implies greater cognitive flexibility at week 4 as compared to week 3 directly after drug administration. |
| Time Frame | Week 3 to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two participants were randomized and took medication (placebo or DCS) at week 3, but were lost to follow up between week 3 and week 4. One participant was randomized at week 3 but did not take medication or complete the ABE exercise at week 3. These three participants are not included in the reported data. |
| Arm/Group Title | Placebo | D-Cycloserine |
|---|---|---|
| Arm/Group Description | Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. |
| Measure Participants | 26 | 29 |
| Mean (Standard Deviation) [Change in a score] |
1.15
(2.80)
|
0.59
(1.84)
|
Adverse Events
| Time Frame | Entire study duration, from Randomization through the final follow-up at Week 36. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE). | |||
| Arm/Group Title | Placebo | D-Cycloserine | ||
| Arm/Group Description | Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits). Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12. | ||
All Cause Mortality |
||||
| Placebo | D-Cycloserine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/28 (85.7%) | 24/30 (80%) | ||
Serious Adverse Events |
||||
| Placebo | D-Cycloserine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 3/30 (10%) | ||
| Infections and infestations | ||||
| Medical Hospitalization | 0/28 (0%) | 0 | 2/30 (6.7%) | 2 |
| Psychiatric disorders | ||||
| Psychiatric Hospitalization | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo | D-Cycloserine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/28 (85.7%) | 24/30 (80%) | ||
| Cardiac disorders | ||||
| Bradycardia | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Hypertension | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Ear Feels Clogged | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Endocrine disorders | ||||
| Blood Sugar Increased | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Eye disorders | ||||
| Blurred Vision | 3/28 (10.7%) | 3 | 1/30 (3.3%) | 1 |
| Eye Hemorrhage | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Gastrointestinal disorders | ||||
| Constipation | 0/28 (0%) | 0 | 2/30 (6.7%) | 2 |
| Diarrhea | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Nausea and Vomiting | 2/28 (7.1%) | 2 | 2/30 (6.7%) | 2 |
| Stomach Pain | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| General disorders | ||||
| Dry Mouth | 2/28 (7.1%) | 2 | 3/30 (10%) | 3 |
| Facial Swelling | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Hair Loss | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Hair Thinning | 1/28 (3.6%) | 2 | 1/30 (3.3%) | 1 |
| Hot Flashes | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Hepatobiliary disorders | ||||
| Frequency of Urination | 0/28 (0%) | 0 | 2/30 (6.7%) | 2 |
| Infections and infestations | ||||
| Common Cold | 4/28 (14.3%) | 5 | 1/30 (3.3%) | 2 |
| Nasal Congestion | 1/28 (3.6%) | 1 | 4/30 (13.3%) | 4 |
| Flu-like Symptoms | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Gingival Bleeding | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Infection | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Upper Respiratory Infection | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Pneumonia and Dehydration | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Appetite Decreased | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Appetite Increased | 2/28 (7.1%) | 2 | 5/30 (16.7%) | 5 |
| Abdominal Discomfort | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Back Ache | 2/28 (7.1%) | 2 | 0/30 (0%) | 0 |
| Back Pain | 3/28 (10.7%) | 4 | 2/30 (6.7%) | 2 |
| Muscle Cramp | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Drooling | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Jaw Pain | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Joint Pain | 1/28 (3.6%) | 2 | 0/30 (0%) | 0 |
| Knee Pain | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Muscle Cramp | 1/28 (3.6%) | 1 | 3/30 (10%) | 3 |
| Muscle Spasm/Twitch | 2/28 (7.1%) | 3 | 1/30 (3.3%) | 1 |
| Muscle Weakness/Fatigue | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Pain | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Foot Pain | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Cyst | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Nervous system disorders | ||||
| Concentration Impaired | 0/28 (0%) | 0 | 2/30 (6.7%) | 2 |
| Impaired Coordination | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Decreased Sleep | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Difficulty Thinking | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Dizziness | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Dizziness Upon Standing | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Drowsiness | 2/28 (7.1%) | 2 | 0/30 (0%) | 0 |
| Drowsy on Awakening | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Falling Down | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| False Sensation | 0/28 (0%) | 0 | 2/30 (6.7%) | 2 |
| Fatigue | 1/28 (3.6%) | 1 | 4/30 (13.3%) | 5 |
| Headache | 2/28 (7.1%) | 3 | 5/30 (16.7%) | 6 |
| Insomnia | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Loss of Consciousness | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Memory Impaired | 1/28 (3.6%) | 1 | 2/30 (6.7%) | 2 |
| Mental Concentration Difficulty | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Mental Dullness | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Nightmares | 2/28 (7.1%) | 3 | 4/30 (13.3%) | 4 |
| Numbness | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Psychiatric disorders | ||||
| Apathy | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Auditory Hallucinations | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Depression | 1/28 (3.6%) | 2 | 0/30 (0%) | 0 |
| Feeling Strange | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Hallucinations | 2/28 (7.1%) | 2 | 1/30 (3.3%) | 1 |
| Irritability | 3/28 (10.7%) | 3 | 5/30 (16.7%) | 5 |
| Nervousness | 0/28 (0%) | 0 | 3/30 (10%) | 3 |
| Panic Attack | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Paranoia | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Anorgasmia | 2/28 (7.1%) | 2 | 0/30 (0%) | 0 |
| Libido Decreased | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Coughing | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Hyperventilation | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Lung Disease Obstruvtive | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Blisters | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Bruise | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Burning Skin | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Dry Skin | 1/28 (3.6%) | 1 | 0/30 (0%) | 0 |
| Skin Irritation | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Social circumstances | ||||
| Incarceration | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
| Vascular disorders | ||||
| Chest Pain | 1/28 (3.6%) | 1 | 1/30 (3.3%) | 1 |
| Faintness | 0/28 (0%) | 0 | 1/30 (3.3%) | 1 |
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Principal Investigator |
|---|---|
| Organization | NYU Langone Health |
| Phone | 646-754-4843 |
| donald.goff@nyumc.org |
- 12-02991