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

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


Condition Intervention Phase
Anxiety Disorders
Somatoform Disorders
Drug: Escitalopram
Drug: Placebo
Drug: Escitalopram extension
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 128
Study Start Date: May 2005
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants taking escitalopram only
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: 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.
2: Placebo Comparator
Participants taking escitalopram then placebo
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149799

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

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Caitlin Taylor, BA     617-643-4779     ctaylor15@partners.org    
Contact: Sabine Wilhelm, PhD     617-724-6146        
Principal Investigator: Sabine Wilhelm, PhD            
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact     401-455-6466        
Principal Investigator: Katharine Phillips, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
Principal Investigator: Katharine Phillips, MD Butler Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Massachusetts General Hospital/Harvard Medical School ( Sabine Wilhelm, PhD )
Study ID Numbers: R01 MH072854, 2004-P-002305, DSIR 83-ATSO
Study First Received: September 6, 2005
Last Updated: July 10, 2009
ClinicalTrials.gov Identifier: NCT00149799     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Body Dysmorphic Disorder
Escitalopram
Lexapro
BDD

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Hypochondriasis
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Somatoform Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009