Trial Outcomes & Findings for D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder (NCT NCT00842309)
NCT ID: NCT00842309
Last Updated: 2019-06-18
Results Overview
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Endpoint (post-treatment, week 11)
Results posted on
2019-06-18
Participant Flow
68 participants consented and screened. Of those, 28 were deemed eligible to participate and randomized to a condition. The remaining 40 participants were excluded for the following reasons: Did not meet criteria (n= 30) Declined to participate (n= 4) Did not show (n= 3) Other (n= 3)
Participant milestones
| Measure |
D-cycloserine-augmented CBT
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Placebo-augmented CBT
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
D-cycloserine-augmented CBT
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Placebo-augmented CBT
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=12 Participants
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Placebo
n=14 Participants
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.92 years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
29.07 years
STANDARD_DEVIATION 11.04 • n=7 Participants
|
26.69 years
STANDARD_DEVIATION 9.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BDD-YBOCS
|
31.75 units on a scale
STANDARD_DEVIATION 5.03 • n=5 Participants
|
30.36 units on a scale
STANDARD_DEVIATION 4.45 • n=7 Participants
|
31 units on a scale
STANDARD_DEVIATION 4.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: Endpoint (post-treatment, week 11)Population: BDD-YBOCS was a clinician-administered measure administered to patients with body dysmorphic disorder.
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
Outcome measures
| Measure |
D-cycloserine
n=11 Participants
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Placebo
n=13 Participants
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
|---|---|---|
|
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
|
19.64 units on a scale
Standard Deviation 6.8
|
18.77 units on a scale
Standard Deviation 10.03
|
PRIMARY outcome
Timeframe: Mid-treatment (week 6)The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
Outcome measures
| Measure |
D-cycloserine
n=12 Participants
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Placebo
n=13 Participants
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
|---|---|---|
|
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
|
21.75 units on a scale
Standard Deviation 5.34
|
20.85 units on a scale
Standard Deviation 8.9
|
Adverse Events
D-cycloserine-augmented CBT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo-augmented CBT
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-cycloserine-augmented CBT
n=14 participants at risk
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
d-cycloserine: 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
Placebo-augmented CBT
n=14 participants at risk
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo: Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
|
|---|---|---|
|
Nervous system disorders
Feeling drowsy or sleepy
|
0.00%
0/14 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
|
Psychiatric disorders
Depressive symptoms
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
|
General disorders
Stress fracture in both arms
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
0.00%
0/14 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis in knee
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
0.00%
0/14 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
|
Skin and subcutaneous tissue disorders
Went to dermatologist for acne and started medication
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
0.00%
0/14 • Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place