D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/17/2019 |
| Start Date: | November 2008 |
| End Date: | August 2018 |
A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for 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.
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.
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.
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.
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
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-4387
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