D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Body Dysmorphic Disorder
Intervention: d-cycloserine (Drug); Placebo (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Sabine Wilhelm, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact: Alexandra Sullivan, BS, Phone: 617-643-4387, Email: adsullivan@mgh.harvard.edu
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.
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Alexandra Sullivan, BS, Phone: 617-643-4387, Email: adsullivan@mgh.harvard.edu
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting Alexandra Sullivan, BS, Phone: 617-643-3487, Email: adsullivan@mgh.harvard.edu
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting Alexandra Sullivan, BS, Phone: 617-643-4387, Email: adsullivan@mgh.harvard.edu
Additional Information
Mass General Hospital BDD clinic website OCD and Related Disorders Clinic at MGH
Starting date: November 2008
Last updated: August 14, 2015
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