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Trial record 38 of 121 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder (BDD/DCS)

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ClinicalTrials.gov Identifier: NCT00842309
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : March 15, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Body Dysmorphic Disorder
Interventions Drug: d-cycloserine
Drug: Placebo
Enrollment 68
Recruitment Details  
Pre-assignment Details 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)
Arm/Group Title D-cycloserine-augmented CBT Placebo-augmented CBT
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 14 [1] 14
Completed 11 13
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             3             1
[1]
14 randomized. 2 withdrew prior to initiating DCS-not included in modified intent-to-treat analyses.
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 12 14 26
Hide Baseline Analysis Population Description
Participants included in modified intent-to-treat (ITT) analyses were 26 adults who completed at least one treatment session in their randomized condition [CBT plus DCS (n = 12); CBT plus placebo (n = 14)]. Note that 2 participants in CBT plus DCS did not complete any sessions in their randomized condition and were excluded from analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 14 participants 26 participants
23.92  (5.74) 29.07  (11.04) 26.69  (9.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
Female
5
  41.7%
12
  85.7%
17
  65.4%
Male
7
  58.3%
2
  14.3%
9
  34.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 26 participants
American Indian or Alaska Native
1
   8.3%
0
   0.0%
1
   3.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   7.1%
1
   3.8%
White
11
  91.7%
11
  78.6%
22
  84.6%
More than one race
0
   0.0%
1
   7.1%
1
   3.8%
Unknown or Not Reported
0
   0.0%
1
   7.1%
1
   3.8%
BDD-YBOCS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 14 participants 26 participants
31.75  (5.03) 30.36  (4.45) 31  (4.68)
[1]
Measure Description: 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 change in BDD symptoms from baseline to endpoint.
1.Primary Outcome
Title Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Hide Description 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.
Time Frame Endpoint (post-treatment, week 11)
Hide Outcome Measure Data
Hide Analysis Population Description
BDD-YBOCS was a clinician-administered measure administered to patients with body dysmorphic disorder.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.64  (6.8) 18.77  (10.03)
2.Primary Outcome
Title Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Hide Description 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.
Time Frame Mid-treatment (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.75  (5.34) 20.85  (8.9)
Time Frame Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine-augmented CBT Placebo-augmented CBT
Hide Arm/Group Description

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 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.

All-Cause Mortality
D-cycloserine-augmented CBT Placebo-augmented CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine-augmented CBT Placebo-augmented CBT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine-augmented CBT Placebo-augmented CBT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      3/14 (21.43%)    
General disorders     
Stress fracture in both arms   1/14 (7.14%)  1 0/14 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Tendonitis in knee   1/14 (7.14%)  1 0/14 (0.00%)  0
Nervous system disorders     
Feeling drowsy or sleepy   0/14 (0.00%)  0 2/14 (14.29%)  2
Psychiatric disorders     
Depressive symptoms  [1]  1/14 (7.14%)  1 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders     
Went to dermatologist for acne and started medication   1/14 (7.14%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
One patient experienced a major depressive episode during the follow-up period. Another patient had an increase in depressive symptoms and suicidal thoughts (no plan) during follow-up.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Hilary Weingarden
Organization: Massachusetts General Hospital
Phone: 617-643-6206
Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842309     History of Changes
Other Study ID Numbers: 2008P001429
First Submitted: February 10, 2009
First Posted: February 12, 2009
Results First Submitted: November 30, 2018
Results First Posted: March 15, 2019
Last Update Posted: June 18, 2019