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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842309
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : March 15, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Drug: d-cycloserine Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
Study Start Date : November 2008
Actual Primary Completion Date : December 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Active Comparator: D-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Drug: d-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Other Name: seromycin

Placebo Comparator: Placebo
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Drug: Placebo
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Other Name: sugar pill




Primary Outcome Measures :
  1. Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) [ Time Frame: Endpoint (post-treatment, week 11) ]
    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.

  2. Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) [ Time Frame: Mid-treatment (week 6) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842309


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Sabine Wilhelm, PhD, Massachusetts General Hospital:
Additional Information:
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Responsible Party: Sabine Wilhelm, PhD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842309    
Other Study ID Numbers: 2008P001429
First Posted: February 12, 2009    Key Record Dates
Results First Posted: March 15, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action