Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
NCT ID: NCT00149799
Last Updated: 2017-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2005-05-31
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Escitalopram
In Phase I, all participants received open-label escitalopram for 14 weeks (at a dosage of 10 mg/d in weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter). Participants who responded to escitalopram in Phase I of the study (Weeks 1-14) were randomized to continue with escitalopram for Phase II of the study (Weeks 16-40)
Escitalopram
At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
Placebo
Participants who responded to escitalopram in Phase I of the study (Weeks 1-14) were randomized to receive a placebo for Phase II of the study (Weeks 16-40)
Placebo
At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Interventions
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Escitalopram
At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
Placebo
At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Alcohol/drug abuse or dependence within 3 months of study entry
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Rhode Island Hospital
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Sabine Wilhelm
PhD
Principal Investigators
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Sabine Wilhelm, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital (MGH)
Katharine Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital (RIH)
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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References
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Fang A, Porth R, Phillips KA, Wilhelm S. Personality as a Predictor of Treatment Response to Escitalopram in Adults With Body Dysmorphic Disorder. J Psychiatr Pract. 2019 Sep;25(5):347-357. doi: 10.1097/PRA.0000000000000415.
Weingarden H, Shaw AM, Phillips KA, Wilhelm S. Shame and Defectiveness Beliefs in Treatment Seeking Patients With Body Dysmorphic Disorder. J Nerv Ment Dis. 2018 Jun;206(6):417-422. doi: 10.1097/NMD.0000000000000808.
Related Links
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Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH
Other Identifiers
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