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

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ClinicalTrials.gov Identifier: NCT00842309
Recruitment Status : Recruiting
First Posted : February 12, 2009
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Drug: d-cycloserine Drug: Placebo Early Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
Study Start Date : November 2008
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) [ Time Frame: mid-treatment and post-treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842309


Contacts
Contact: Eliza Davidson, BS 617-643-4357 ejdavidson@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eliza Davidson, BS    617-643-4357    ejdavidson@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
More Information

Additional Information:
Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842309     History of Changes
Other Study ID Numbers: 2008P001429
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016

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