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

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Cycloserine

Criteria

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