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Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorders; Somatoform Disorders

Intervention: Escitalopram (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Sabine Wilhelm, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital (MGH)
Katharine Phillips, MD, Principal Investigator, Affiliation: Rhode Island Hospital (RIH)

Summary

This study's primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram.

Clinical Details

Official title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)

Secondary outcome:

Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)

Q-LES-Q Short Form

Psychosocial Functioning (as Measured by the LIFE-RIFT)

Depressive Symptoms (as Measured by the HAM-D)

Detailed description: We propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic disorder (BDD). BDD, an often-delusional preoccupation with a nonexistent or slight defect in appearance, is a distressing, impairing, and common body image disorder. It is associated with high rates of functional impairment and markedly poor quality of life. It appears that serotonin reuptake inhibitors (SRIs) are often--and selectively--efficacious for BDD and that many BDD patients receive SRIs. It also appears that most patients discontinue an efficacious SRI at some point, as the alternative is life-long treatment. However, no relapse prevention studies have been done. Such a study is important from a clinical and public health perspective, because BDD appears to often be chronic and require long-term treatment. It is therefore critically important to investigate the risk of relapse with SRI discontinuation, and whether continuation SRI treatment decreases relapse risk. Subjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58 escitalopram responders will then be randomized to double-blind continuation treatment with escitalopram or placebo for 6 additional months. Our primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram. Secondary/exploratory aims will explore 1) Whether subjects who receive continuation escitalopram perform better on secondary outcome measures (e. g., quality of life) than those on placebo; 2) Change in symptoms with continuation of escitalopram during the continuation phase; and 3) Acute treatment response. In summary, this study will be the first relapse prevention study in BDD and the first study of continuation pharmacotherapy in BDD. It will provide critically important information on relapse with continuation versus discontinuation of an SRI, whether continuation treatment protects against relapse, and change in symptoms with continuation treatment. This study will yield unique and clinically important data, and will fill gaps in knowledge about this common, severe, and understudied illness.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatient men and women age 18 and older

- Diagnosis of BDD within 6 months of study start date based on the Diagnostic and

Statistical Manual of Mental Disorders (DSM-IV)

- 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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Rhode Island Hospital, Providence, Rhode Island 02906, United States

Additional 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 RIH

Starting date: May 2005
Last updated: November 14, 2014

Page last updated: August 23, 2015

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