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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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 ]

Enrollment: 104
Study Start Date: May 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram
Participants taking Escitalopram only for both Phase I and Phase II of the trial
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: 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.
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)
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149799

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Massachusetts General Hospital
Rhode Island Hospital
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: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00149799     History of Changes
Other Study ID Numbers: R01 MH072854, R01MH072854, 2004-P-002305, DSIR 83-ATSO
Study First Received: September 6, 2005
Last Updated: April 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Body Dysmorphic Disorder
Escitalopram
Lexapro
BDD
Body Image

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

ClinicalTrials.gov processed this record on September 18, 2014