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Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder - Article


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Clinical Trial: Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00149799

Purpose

This study will assess the relapse-prevention rate of escitalopram (Lexapro) in the treatment of Body Dysmorphic Disorder.
Condition Intervention Phase
Anxiety Disorders
Somatoform Disorders
 Drug: Escitalopram (Lexapro)
Phase IV

MedlinePlus related topics:  Anxiety;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

Further Study Details: 
Primary Outcomes: Relapse of Body Dysmorphic Disorder Symptoms, Month 6
Secondary Outcomes: At each study visit:; Functioning and life satisfaction; Depressive symptoms; Anxiety symptoms
Expected Total Enrollment:  128

Study start: May 2005

Body Dysmorphic Disorder (BDD) is a mental disorder in which a person is preoccupied by a very slight physical anomaly or an imagined defect in his or her appearance. It is associated with Obsessive Compulsive Disorder (OCD). Treatment of BDD usually reduces symptoms of the disorder, but some people’s symptoms regress only for a short time and then reappear. Drugs that will reduce the risk of BDD-relapse are needed. Escitalopram, also known as Lexapro, is a serotonin reuptake inhibitor (SRI). It is an oral drug used to treat depression and general anxiety disorder. Its ability to prevent relapse of BDD has not yet been studied. This study will evaluate the relapse-prevention rate of escitalopram for the treatment of BDD.

The study will start with an open-label phase, during which all participants will receive escitalopram for 14 weeks. Study visits will occur once weekly for the first month and once every other week for the remainder of the 14 weeks. At the end of this initial phase, those who show improvement will continue into a double-blind phase. The remaining participants will be randomly assigned to receive either escitalopram or placebo for an additional 6 months. Study visits will occur once every other week, with an additional visit at Week 15. Participants’ improvement or return of BDD-related symptoms will be assessed. Throughout the 6 months, any participant showing relapse will be referred to alternate treatment.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of BDD within 6 months of study start date
  • Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale
  • Lives within driving distance of Boston, MA or Providence, RI

Exclusion Criteria:

  • Alcohol/Drug abuse or dependence within 3 months of study entry
  • Suicidal or homicidal tendencies

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00149799

Kara L. Watts      (617) 643-3079    KLWatts@partners.org

Massachusetts
      Body Dysmorphic Disorder Clinic, Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Kara Watts  617-643-3079    klwatts@partners.org 
Sabine Wilhelm, PhD,  Principal Investigator

Rhode Island
      Body Image Program, Butler Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
Mary Walters, Ed.M.  401-455-6466 
Katharine Phillips, MD,  Principal Investigator

Study chairs or principal investigators

Sabine Wilhelm, PhD,  Principal Investigator,  Massachusetts General Hospital   
Katharine Phillips, MD,  Principal Investigator,  Butler Hospital   

More Information

Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH

Click here to go to the official website of the Body Image Program at Butler Hospital

Study ID Numbers:  MH72854-01; 2004-P-002305
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149799
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13

Resources



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Page Updated: September 30, 2005
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