- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00842309
D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder (BDD/DCS)
June 6, 2019 updated by: Sabine Wilhelm, PhD, Massachusetts General Hospital
A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD).
Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
- BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
- Females of childbearing potential must have a negative urinary beta-HCG test
- Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures
Exclusion Criteria:
- Pregnant or breastfeeding women will be excluded
- People taking medications that may interfere with DCS
- History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
- Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem
- Those deemed to pose a serious suicidal or homicidal threat will be excluded
- Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: D-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
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100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Other Names:
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Placebo Comparator: Placebo
Placebo 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Time Frame: Endpoint (post-treatment, week 11)
|
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.
|
Endpoint (post-treatment, week 11)
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Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Time Frame: 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.
|
Mid-treatment (week 6)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
February 10, 2009
First Submitted That Met QC Criteria
February 10, 2009
First Posted (Estimate)
February 12, 2009
Study Record Updates
Last Update Posted (Actual)
June 18, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008P001429
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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