Early Phase 1
N=28
D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder
Body Dysmorphic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00842309 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) — 19.64; 18.77 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- d-cycloserine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) |
21.75; 20.85 | — |
| PRIMARY Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) |
21.75; 20.85 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00842309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.