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
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