Ear Disorders |
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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
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Purpose
| 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
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
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
Massachusetts
Body Dysmorphic Disorder Clinic, Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Sabine Wilhelm, PhD, Principal Investigator
Rhode Island
Body Image Program, Butler Hospital, Providence, Rhode Island, 02906, United States; Recruiting
Katharine Phillips, MD, Principal Investigator
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
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
- About Faces: The Ears (National Institute for Dental and Craniofacial Research)
- Airplane Ear (MayoClinic)

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