D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder

Conditions
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Body Dysmorphic Disorder

Intervention / Treatment
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* Drug: d-cycloserine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D-cycloserine<br>100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. | Drug: d-cycloserine<br>* 100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.<br>* Other names: seromycin;|
| Placebo Comparator: Placebo<br>Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. | Drug: Placebo<br>* Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 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) | 
| Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) | 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) |