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Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
Official Title  Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder
Brief Summary

This study will assess the relapse-prevention rate of escitalopram (Lexapro) in the treatment of body dysmorphic disorder.

Detailed Description

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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Relapse of Body Dysmorphic Disorder Symptoms [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Functioning and life satisfaction [ Time Frame: Measured at Month 10 ] [ Designated as safety issue: No ]
Depressive symptoms [ Time Frame: Measured at Month 10 ] [ Designated as safety issue: No ]
Anxiety symptoms [ Time Frame: Measured at Month 10 ] [ Designated as safety issue: No ]
Condition  Anxiety Disorders
Somatoform Disorders
Intervention  Drug: Escitalopram
Drug: Placebo
Drug: Escitalopram extension
MEDLINE PMIDs
Links Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH This link exits the ClinicalTrials.gov site
Click here to go to the official website of the Body Image Program at Butler Hospital This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  128
Start Date  May 2005
Completion Date February 2010
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Angela Fang, BA     617-643-4779     Afang@partners.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00149799
Organization ID R01 MH72854
Secondary IDs †† 2004-P-002305, DSIR 83-ATSO
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Sabine Wilhelm, PhD     Massachusetts General Hospital    
Principal Investigator:     Katharine Phillips, MD     Butler Hospital    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  September 6, 2005
Last Updated Date February 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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