Official Title: “Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • All participants will receive escitalopram for 14 weeks. The dosages will be 10 mg for 2 weeks, 20 mg for 2 weeks, and 30 mg for 10 weeks.
• Drug: Placebo
  • After the initial 14 weeks of escitalopram treatment, participants then randomly assigned to placebo will take placebo capsules for an additional 6 months.
• Drug: Escitalopram extension
  • At the end of the initial 14-week phase, participants then randomly assigned to escitalopram will receive treatment with escitalopram for an additional 6 months.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants taking escitalopram only
• Placebo Comparator: 2
  • Participants taking escitalopram then placebo

Primary Measures

• Relapse of Body Dysmorphic Disorder Symptoms (as measured by the BDD-YBOCS)
  • Time Frame: Biweekly for six months after randomization
    Safety Issue?: No

Secondary Measures

• Functioning and life satisfaction (as measured by the LIFE)
  • Time Frame: Measured four times throughout study (Screening, EW14, EW28 and EW40)
    Safety Issue?: No
• Depressive symptoms (as measured by the BDI-II)
  • Time Frame: Measured biweekly for six months after randomization
    Safety Issue?: No
• Anxiety symptoms (as measured by the SIGH-D)
  • Time Frame: Measured at every study visit for 40 weeks
    Safety Issue?: No
• Delusionality of BDD symptoms (as measured by the BABS)
  • Time Frame: Measured at every study visit for 40 weeks
    Safety Issue?: No

Inclusion Criteria:

• Outpatient men and women age 18 and older
• 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:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Sabine Wilhelm, PhD Principal Investigator Massachusetts General Hospital  

Overall Contact: Angela Fang, BA 1-877-4-MGH-BDD bdd@partners.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149799

Study ID Number: R01 MH072854

ClinicalTrials.gov Identifier: NCT00149799

Health Authority: United States: Federal Government

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