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D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder (BDD/DCS)

Primary Purpose

Body Dysmorphic Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
d-cycloserine
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

D-cycloserine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2009
Last Updated
June 6, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00842309
Brief Title
D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder
Acronym
BDD/DCS
Official Title
A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-cycloserine
Arm Type
Active Comparator
Arm Description
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
d-cycloserine
Other Intervention Name(s)
seromycin
Intervention Description
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Primary Outcome Measure Information:
Title
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Description
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.
Time Frame
Endpoint (post-treatment, week 11)
Title
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Description
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.
Time Frame
Mid-treatment (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
http://mghocd.org/
Description
Mass General Hospital BDD clinic website
URL
http://www.mghocd.org
Description
OCD and Related Disorders Clinic at MGH

Learn more about this trial

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

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