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

Mass General Brigham

Status and phase: Completed; Early Phase 1

Conditions: Body Dysmorphic Disorder

Treatments: Drug: d-cycloserine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00842309

2008P001429

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

D-cycloserine

Active Comparator group

Description:

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

Treatment:

Drug: d-cycloserine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo