Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00149799
First received: September 6, 2005
Last updated: April 22, 2013
Last verified: April 2013

September 6, 2005
April 22, 2013
May 2005
March 2013   (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
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Somatoform Disorders
  • 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.
    Other Name: Lexapro
  • 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.
  • Experimental: Escitalopram
    Participants taking Escitalopram only for both Phase I and Phase II of the trial
    Interventions:
    • Drug: Escitalopram
    • Drug: Escitalopram extension
  • Placebo Comparator: Placebo
    Participants taking Escitalopram for Phase I of the study (Weeks 1-14) followed by a placebo for Phase II of the study (Weeks 16-40)
    Interventions:
    • Drug: Escitalopram
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
March 2013
March 2013   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00149799
R01 MH072854, R01MH072854, 2004-P-002305, DSIR 83-ATSO
Yes
Sabine Wilhelm, Massachusetts General Hospital
Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)
  • Rhode Island Hospital
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
Principal Investigator: Katharine Phillips, MD Butler Hospital
Massachusetts General Hospital
April 2013

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