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Trial record 56 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-Cycloserine Enhancement of Exposure in Social Phobia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00633984
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : May 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Collaborators:
Boston University
Southern Methodist University
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Social Anxiety Disorder
Interventions Behavioral: Cognitive Behavioral Group Therapy (CBGT)
Drug: D-Cycloserine
Drug: Placebo
Enrollment 169
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Behavioral Group Therapy + 50mg D-Cycloserine Cognitive Behavioral Group Therapy + 50mg Placebo
Hide Arm/Group Description Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine. Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
Period Title: Overall Study
Started 87 82
Completed 78 69
Not Completed 9 13
Reason Not Completed
Lost to Follow-up             0             6
Withdrawal by Subject             8             7
Hospitalized             1             0
Arm/Group Title Cognitive Behavioral Group Therapy + 50mg D-Cycloserine Cognitive Behavioral Group Therapy + 50mg Placebo Total
Hide Arm/Group Description Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine. Participants received Cognitive Behavioral Group Therapy and 50mg Placebo. Total of all reporting groups
Overall Number of Baseline Participants 87 82 169
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 82 participants 169 participants
34.6  (10.5) 30.5  (9.8) 32.6  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 82 participants 169 participants
Female
31
  35.6%
42
  51.2%
73
  43.2%
Male
56
  64.4%
40
  48.8%
96
  56.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 87 participants 82 participants 169 participants
87 82 169
1.Primary Outcome
Title Liebowitz Social Anxiety Scale (LSAS)
Hide Description The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale
Time Frame Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Group Therapy + 50mg D-Cycloserine Cognitive Behavioral Group Therapy + 50mg Placebo
Hide Arm/Group Description:
Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
Overall Number of Participants Analyzed 87 82
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
39.19
(34.79 to 43.59)
42.44
(37.94 to 47.03)
2.Primary Outcome
Title CGI - Clinical Global Impression of Improvement
Hide Description The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 ("very much improved") to 7 ("very much worse"). Response and remission was defined as an improvement score of 1 ("very much improved") or 2 ("much improved") on the CGI-I.
Time Frame Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Group Therapy + 50mg D-Cycloserine Cognitive Behavioral Group Therapy + 50mg Placebo
Hide Arm/Group Description:
Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
Overall Number of Participants Analyzed 87 82
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.68
(2.38 to 2.98)
2.95
(2.64 to 3.27)
Time Frame Adverse event data were collected for 6 weeks.
Adverse Event Reporting Description Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
 
Arm/Group Title Cognitive Behavioral Therapy + DCS Cognitive Behavioral Therapy + Placebo
Hide Arm/Group Description Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine. Participants received Cognitive Behavioral Group Therapy and Placebo.
All-Cause Mortality
Cognitive Behavioral Therapy + DCS Cognitive Behavioral Therapy + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Therapy + DCS Cognitive Behavioral Therapy + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/82 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Behavioral Therapy + DCS Cognitive Behavioral Therapy + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/87 (29.89%)   19/82 (23.17%) 
General disorders     
General   7/87 (8.05%)  4/82 (4.88%) 
Neurological   6/87 (6.90%)  4/82 (4.88%) 
GI   5/87 (5.75%)  4/82 (4.88%) 
Cognitive/Emotional   3/87 (3.45%)  1/82 (1.22%) 
Genitourinary   0/87 (0.00%)  1/82 (1.22%) 
Other   6/87 (6.90%)  5/82 (6.10%) 
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
Name/Title: Dr. Stefan G. Hofmann
Organization: Boston University
Phone: 617 353 9233
Responsible Party: Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00633984     History of Changes
Other Study ID Numbers: 2007-P-000386
R01MH075889 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2008
First Posted: March 12, 2008
Results First Submitted: January 2, 2014
Results First Posted: May 14, 2014
Last Update Posted: May 14, 2014