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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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Body Dysmorphic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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D-cycloserine

100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Group Type ACTIVE_COMPARATOR

d-cycloserine

Intervention Type DRUG

100mg of d-cycloserine 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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Interventions

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d-cycloserine

100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Intervention Type DRUG

Placebo

Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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seromycin sugar pill

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No