D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder

NCT00842309 | Completed Early Phase 1 Results

• 1 other identifier: 2008P001429
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Dysmorphic Disorder

Outcome Measures

Primary Outcomes (2)

• Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

  The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.

  Endpoint (post-treatment, week 11)

• Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

  The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.

  Mid-treatment (week 6)

Study Arms (2)

D-cycloserine

ACTIVE COMPARATOR

100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Drug: d-cycloserine

Placebo

PLACEBO COMPARATOR

Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Drug: Placebo

Interventions

d-cycloserine DRUG

100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Also known as: seromycin

D-cycloserine

Placebo DRUG

Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Mass General Hospital BDD clinic website
• OCD and Related Disorders Clinic at MGH

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Cycloserine; Sugars

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Results Point of Contact

• Title: Dr. Hilary Weingarden
• Organization: Massachusetts General Hospital

hilary_weingarden@mgh.harvard.edu

617-643-6206

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 12, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: June 18, 2019
• Results First Posted: March 15, 2019

Record last verified: 2019-06

Locations

US (1)