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| Descriptive Information Fields | |||||||||
| Brief Title † | Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder | ||||||||
| Official Title † | Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder | ||||||||
| Brief Summary | This study will assess the relapse-prevention rate of escitalopram (Lexapro) in the treatment of body dysmorphic disorder. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Relapse of Body Dysmorphic Disorder Symptoms [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Functioning and life satisfaction [ Time Frame: Measured at Month 10 ] [ Designated as safety issue: No ] Depressive symptoms [ Time Frame: Measured at Month 10 ] [ Designated as safety issue: No ] Anxiety symptoms [ Time Frame: Measured at Month 10 ] [ Designated as safety issue: No ] |
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| Condition † | Anxiety Disorders Somatoform Disorders |
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| Intervention † | Drug: Escitalopram Drug: Placebo Drug: Escitalopram extension |
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| MEDLINE PMIDs | |||||||||
| Links | 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 Butler Hospital |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 128 | ||||||||
| Start Date † | May 2005 | ||||||||
| Completion Date | February 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00149799 | ||||||||
| Organization ID | R01 MH72854 | ||||||||
| Secondary IDs †† | 2004-P-002305, DSIR 83-ATSO | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | September 6, 2005 | ||||||||
| Last Updated Date | February 12, 2008 | ||||||||
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