Trial Outcomes & Findings for Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy (NCT NCT00182000)
NCT ID: NCT00182000
Last Updated: 2012-07-16
Results Overview
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).
COMPLETED
PHASE3
33 participants
Post-treatment (week 5)
2012-07-16
Participant Flow
33 participants enrolled in the study. However, 4 participants decided not to participate in between consenting and starting treatment.
Participant milestones
| Measure |
Seromycin
10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
|
Placebo
10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy
Baseline characteristics by cohort
| Measure |
Seromycin
n=14 Participants
10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
|
Placebo
n=15 Participants
10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38.29 years
STANDARD_DEVIATION 13.01 • n=5 Participants
|
38.07 years
STANDARD_DEVIATION 12.28 • n=7 Participants
|
38.18 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (week 5)Population: 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.
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).
Outcome measures
| Measure |
Seromycin
n=10 Participants
10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
|
Placebo
n=13 Participants
10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale (YBOCS)
|
10.2 units on a scale
Standard Deviation 7.2
|
14.5 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Post-treatment (week 5)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-treatment (week 5)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-treatment (week 5)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-treatment (week 5)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-treatment (week 5)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-treatment (week 5)Outcome measures
Outcome data not reported
Adverse Events
Seromycin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place