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

Early Phase 1

Completed

• Conditions: Body Dysmorphic Disorder
• Interventions: Drug: Placebo; Drug: d-cycloserine

• Registration Number: NCT00842309
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-12
• Primary Completion: 2017-12
• Study Completion: 2018-08
• Results First Submitted: 2018-11-30
• Results First Submitted QC: 2018-11-30
• Results First Posted: 2019-03-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States