D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder (BDD/DCS)
This study is currently recruiting participants.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00842309
First received: February 10, 2009
Last updated: April 22, 2013
Last verified: April 2013
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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 2013 |
| Estimated Primary Completion Date: | December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842309
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Natalie Matheny, BA 617-724-4354 nmatheny@partners.org | |
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: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Body Dysmorphic Disorders 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 May 19, 2013