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

Body Dysmorphic Disorder Clinical Trial

— BDD/DCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842309
• Other study ID #: 2008P001429
• Status: Completed
• Phase: Early Phase 1
• Start date: November 2008
• Est. completion date: August 2018

Study information

• Verified date: June 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Disease

Intervention

Drug:
• d-cycloserine
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)

External Links

•   Mass General Hospital BDD clinic website
•   OCD and Related Disorders Clinic at MGH