Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

Condition(s) targeted: Anxiety Disorders; Somatoform Disorders

Intervention: Escitalopram (Drug); Placebo (Drug); Escitalopram extension (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Sabine Wilhelm, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital
Katharine Phillips, MD, Principal Investigator, Affiliation: Butler Hospital

Overall contact:
Caitlin Taylor, BA, Phone: 1-877-4-MGH-BDD, Email: bdd@partners.org

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

Official title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

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

Primary outcome: Relapse of Body Dysmorphic Disorder Symptoms (as measured by the BDD-YBOCS)

Secondary outcome:

Functioning and life satisfaction (as measured by the LIFE)

Depressive symptoms (as measured by the BDI-II)

Anxiety symptoms (as measured by the SIGH-D)

Delusionality of BDD symptoms (as measured by the BABS)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Caitlin Taylor, BA, Phone: 1-877-4-MGH-BDD, Email: bdd@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Caitlin Taylor, BA, Phone: 617-643-4779, Email: ctaylor15@partners.org
Sabine Wilhelm, PhD, Phone: 617-724-6146
Sabine Wilhelm, PhD, Principal Investigator

Butler Hospital, Providence, Rhode Island 02906, United States; Recruiting
Phone: 401-455-6466
Katharine Phillips, MD, Principal Investigator

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

Starting date: May 2005
Ending date: February 2010
Last updated: July 10, 2009