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Trial record 57 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy

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ClinicalTrials.gov Identifier: NCT00182000
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : July 6, 2012
Last Update Posted : July 16, 2012
Sponsor:
Collaborator:
Hartford Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obsessive-Compulsive Disorder
Interventions Drug: seromycin
Behavioral: Behavior Therapy
Enrollment 33
Recruitment Details  
Pre-assignment Details 33 participants enrolled in the study. However, 4 participants decided not to participate in between consenting and starting treatment.
Arm/Group Title Seromycin Placebo
Hide Arm/Group Description 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
Period Title: Overall Study
Started 14 15
Completed 9 13
Not Completed 5 2
Arm/Group Title Seromycin Placebo Total
Hide Arm/Group Description 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
15
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
38.29  (13.01) 38.07  (12.28) 38.18  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
6
  42.9%
6
  40.0%
12
  41.4%
Male
8
  57.1%
9
  60.0%
17
  58.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
1.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale (YBOCS)
Hide Description A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).
Time Frame Post-treatment (week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
Thirty-three participants were enrolled. Four participants decided not to participate in between enrolling and beginning treatment. Six participants withdrew from the study before the mid-treatment evaluation; 1 participant withdrew from the study after the mid-treatment evaluation, and this participant's data was carried forward.
Arm/Group Title Seromycin Placebo
Hide Arm/Group Description:
10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.2  (7.2) 14.5  (6.4)
2.Secondary Outcome
Title Clinical Global Impressions Scale (CGI)
Hide Description [Not Specified]
Time Frame Post-treatment (week 5)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description [Not Specified]
Time Frame Post-treatment (week 5)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description [Not Specified]
Time Frame Post-treatment (week 5)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Obsessional Beliefs Questionnaire (OBQ)
Hide Description [Not Specified]
Time Frame Post-treatment (week 5)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Short-Form Health Survey (SF-36)
Hide Description [Not Specified]
Time Frame Post-treatment (week 5)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Disability Inventory
Hide Description [Not Specified]
Time Frame Post-treatment (week 5)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seromycin Placebo
Hide Arm/Group Description 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
All-Cause Mortality
Seromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Seromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Seromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sabine Wilhelm, PhD
Organization: Massachusetts General Hospital
Phone: 6177246146
Responsible Party: Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182000     History of Changes
Other Study ID Numbers: 2003-P-001325
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: May 1, 2012
Results First Posted: July 6, 2012
Last Update Posted: July 16, 2012