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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00842309
First received: February 10, 2009
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Body Dysmorphic Disorder
Drug: d-cycloserine
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) [ Time Frame: mid-treatment and post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: D-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Drug: d-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Other Name: seromycin
Placebo Comparator: Placebo
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Drug: Placebo
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Other Name: sugar pill

Detailed Description:

This treatment study also provides us with the opportunity to further explore the molecular genetics of BDD, as well as the genetic predictors of response to an extinction-based treatment. We will take a hypothesis-driven approach by focusing on genes and systems previously shown to mediate fear acquisition and NMDA-dependent extinction learning including NMDA-related glutamatergic loci (GRIN1, GRIN2A, GRIN2B, DAAO, DAOA) and three other genes strongly implicated in fear extinction (BDNF, NTRK2, CNR1). Other loci of interest in the molecular genetics of BDD include: the serotonin transporter gene, dopamine, GABA-A, and cytochrome P450 genes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842309

Contacts
Contact: Alexandra Sullivan, BS 617-643-4387 adsullivan@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexandra Sullivan, BS    617-643-3487    adsullivan@mgh.harvard.edu   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexandra Sullivan, BS    617-643-4387    adsullivan@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842309     History of Changes
Other Study ID Numbers: 2008P001429
Study First Received: February 10, 2009
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Body Dysmorphic Disorders
Pathologic Processes
Somatoform Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014