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Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
This study is currently recruiting participants.
Study NCT00149799   Information provided by National Institute of Mental Health (NIMH)
First Received: September 6, 2005   Last Updated: July 10, 2009   History of Changes

September 6, 2005
July 10, 2009
May 2005
February 2010   (final data collection date for primary outcome measure)
Relapse of Body Dysmorphic Disorder Symptoms (as measured by the BDD-YBOCS) [ Time Frame: Biweekly for six months after randomization ] [ Designated as safety issue: No ]
Relapse of Body Dysmorphic Disorder Symptoms, Month 6
Complete list of historical versions of study NCT00149799 on ClinicalTrials.gov Archive Site
  • Functioning and life satisfaction (as measured by the LIFE) [ Time Frame: Measured four times throughout study (Screening, EW14, EW28 and EW40) ] [ Designated as safety issue: No ]
  • Depressive symptoms (as measured by the BDI-II) [ Time Frame: Measured biweekly for six months after randomization ] [ Designated as safety issue: No ]
  • Anxiety symptoms (as measured by the SIGH-D) [ Time Frame: Measured at every study visit for 40 weeks ] [ Designated as safety issue: No ]
  • Delusionality of BDD symptoms (as measured by the BABS) [ Time Frame: Measured at every study visit for 40 weeks ] [ Designated as safety issue: No ]
  • At each study visit:
  • Functioning and life satisfaction
  • Depressive symptoms
  • Anxiety symptoms
 
Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
  • Anxiety Disorders
  • Somatoform Disorders
  • Drug: Escitalopram
  • Drug: Placebo
  • Drug: Escitalopram extension
  • Experimental: Participants taking escitalopram only
  • Placebo Comparator: Participants taking escitalopram then placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
128
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Caitlin Taylor, BA 1-877-4-MGH-BDD bdd@partners.org
United States
 
NCT00149799
Sabine Wilhelm, PhD, Massachusetts General Hospital/Harvard Medical School
R01 MH072854, 2004-P-002305, DSIR 83-ATSO
National Institute of Mental Health (NIMH)
 
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
Principal Investigator: Katharine Phillips, MD Butler Hospital
National Institute of Mental Health (NIMH)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP