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Completed

NCT Number: NCT00842309

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

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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Key information

Conditions

Body Dysmorphic Disorder Body Dysmorphic Disorders Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-cycloserine

Drug

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

Other names: seromycin

Placebo

Drug

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

Other names: sugar pill

Primary outcomes

  1. Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

    Time frame: Endpoint (post-treatment, week 11)

    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.

  2. Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: BDD/DCS

Important dates

Study start
2008
Primary completion
2017
Study completion
2018
First posted
Feb 12, 2009
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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