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Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

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ClinicalTrials.gov Identifier: NCT01178671
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : February 29, 2016
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Franklin Schneier, Research Foundation for Mental Hygiene, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Interventions Drug: Mirtazapine
Drug: Sertraline
Other: Sugar pill
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Period Title: Overall Study
Started 18 18
Completed 6 3
Not Completed 12 15
Reason Not Completed
Adverse Event             4             6
Protocol Violation             1             1
Lack of Efficacy             0             1
Lost to Follow-up             3             1
Physician Decision             4             6
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill Total
Hide Arm/Group Description

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
18
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
37.6  (11.7) 42.4  (13.3) 40.0  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
12
  66.7%
11
  61.1%
23
  63.9%
Male
6
  33.3%
7
  38.9%
13
  36.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
white 4 5 9
black 4 3 7
other 10 10 20
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 36 participants
18 18 36
Hamilton Rating Scale for Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
20.8  (6.2) 20.4  (5.9) 20.6  (6.0)
[1]
Measure Description: Measures severity of depression on scale from 0 (not depressed) to 50 (most severe).
Posttraumatic Stress Disorder Checklist   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
58.9  (11.0) 60.0  (10.5) 59.5  (10.8)
[1]
Measure Description: Measures severity of posttraumatic stress disorder symptoms from 17 (mildest) to 85 (most severe).
Quality of Life Enjoyment and Satisfaction Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
39.1  (13.6) 41.4  (13.5) 40.2  (13.4)
[1]
Measure Description: Measures quality of life from 16 (lowest quality) to 80 (greatest).
Medical Outcomes Study Short Form 12 - Physical   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
43.9  (9.8) 41.4  (10.6) 42.7  (10.1)
[1]
Measure Description: Measures level of physical functioning from 0 (worst) to 100 (best).
Medical Outcomes Study Short Form 12 - Mental   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
30.3  (13.5) 30.4  (10.0) 30.4  (11.7)
[1]
Measure Description: Measures level of mental functioning from 0 (worst) to 100 (best).
Pittsburgh Sleep Quality Index Global   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
11.5  (4.9) 12.8  (3.1) 12.1  (4.1)
[1]
Measure Description: Measures severity of sleep impairment from 0 (least impairment) to 21 (most severe).
Pittsburgh Sleep Quality Index Addendum for PTSD   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
10.0  (4.9) 11.2  (5.6) 10.6  (5.2)
[1]
Measure Description: Measure severity of sleep impairment related to posttraumatic stress disorder symptoms on a scale from 0 (least impairment) to 100 (most impairment)
Clinician Administered PTSD Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
77.9  (19.5) 81.3  (12.2) 79.6  (16.2)
[1]
Measure Description: Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 136 (most severe).
1.Primary Outcome
Title PTSD Severity
Hide Description PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat sample
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.8  (17.4) 34.6  (17.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Time to Discontinuation of Study Treatment
Hide Description [Not Specified]
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: days
95.2  (73.1) 90.0  (14.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Alternative Measure of PTSD Severity
Hide Description as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
completers
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (2.9) 6.7  (5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .14
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title PTSD Self-rated Severity
Hide Description as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
completers
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
33.2  (18.4) 39.2  (18.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .50
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Depression Severity
Hide Description as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.4  (6.1) 11.6  (6.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Response Status
Hide Description Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of subjects
56 22
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Remission Status
Hide Description Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of subjects
39 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
1.1 to 19.9
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Adverse Effects
Hide Description as assessed by Side Effect Checklist
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of subject dropped due to AEs
22.2 33.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Sleep Quality
Hide Description as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (4.2) 9.1  (4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Sexual Functioning
Hide Description as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description:

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.3  (4.3) 17.4  (8.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline and Mirtazapine, Sertraline and Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sertraline and Mirtazapine Sertraline and Sugar Pill
Hide Arm/Group Description

Flexible dose of both medications for up to 24 weeks

Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sertraline and Sugar pill for up to 24 weeks

Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

All-Cause Mortality
Sertraline and Mirtazapine Sertraline and Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sertraline and Mirtazapine Sertraline and Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline and Mirtazapine Sertraline and Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   18/18 (100.00%)   18/18 (100.00%) 
Blood and lymphatic system disorders     
bruising   0/18 (0.00%)  1/18 (5.56%) 
Eye disorders     
blurry vision   4/18 (22.22%)  2/18 (11.11%) 
Gastrointestinal disorders     
heartburn   5/18 (27.78%)  3/18 (16.67%) 
nausea   2/18 (11.11%)  8/18 (44.44%) 
emesis   2/18 (11.11%)  3/18 (16.67%) 
decreased appetite   3/18 (16.67%)  5/18 (27.78%) 
increased appetite   9/18 (50.00%)  2/18 (11.11%) 
dry mouth   3/18 (16.67%)  5/18 (27.78%) 
constipation   3/18 (16.67%)  5/18 (27.78%) 
diarrhea   6/18 (33.33%)  5/18 (27.78%) 
General disorders     
fatigue   1/18 (5.56%)  6/18 (33.33%) 
Nervous system disorders     
headache   4/18 (22.22%)  3/18 (16.67%) 
restlessness   2/18 (11.11%)  1/18 (5.56%) 
tremor   5/18 (27.78%)  5/18 (27.78%) 
nervousness   1/18 (5.56%)  1/18 (5.56%) 
incoordination   3/18 (16.67%)  2/18 (11.11%) 
insomnia   2/18 (11.11%)  2/18 (11.11%) 
somnolence   6/18 (33.33%)  5/18 (27.78%) 
lightheadedness   9/18 (50.00%)  4/18 (22.22%) 
forgetfulness   4/18 (22.22%)  4/18 (22.22%) 
impaired concentration   2/18 (11.11%)  4/18 (22.22%) 
apathy   2/18 (11.11%)  3/18 (16.67%) 
Renal and urinary disorders     
urinary dysfunction   5/18 (27.78%)  5/18 (27.78%) 
Reproductive system and breast disorders     
decreased libido (men)   0/6 (0.00%)  3/7 (42.86%) 
decreased libido (women)   5/12 (41.67%)  3/11 (27.27%) 
sexual dysfunction (men)   0/6 (0.00%)  3/7 (42.86%) 
sexual dysfunction (women)   1/12 (8.33%)  2/11 (18.18%) 
Skin and subcutaneous tissue disorders     
sweating   4/18 (22.22%)  5/18 (27.78%) 
skin problems   4/18 (22.22%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Franklin Schneier MD
Organization: Research Foundation for Mental Hygiene
Phone: 6467748041
EMail: fschneier@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Franklin Schneier, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01178671    
Other Study ID Numbers: R34MH091336 ( U.S. NIH Grant/Contract )
R34MH091336 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2010
First Posted: August 10, 2010
Results First Submitted: December 8, 2015
Results First Posted: February 29, 2016
Last Update Posted: April 8, 2016