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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00149799 |
This study will assess the relapse-prevention rate of escitalopram (Lexapro) in the treatment of body dysmorphic disorder.
Condition | Intervention | Phase |
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Anxiety Disorders Somatoform Disorders |
Drug: Escitalopram Drug: Placebo Drug: Escitalopram extension |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder |
Estimated Enrollment: | 128 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants taking escitalopram only
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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.
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.
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2: Placebo Comparator
Participants taking escitalopram then placebo
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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.
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angela Fang, BA | 617-643-4779 | Afang@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Angela Fang, BA 617-643-4779 Afang@partners.org | |
Contact: Sabine Wilhelm 617-724-6146 | |
Principal Investigator: Sabine Wilhelm, PhD | |
United States, Rhode Island | |
Butler Hospital | Recruiting |
Providence, Rhode Island, United States, 02906 | |
Contact: Christine Walters 401-455-6466 | |
Principal Investigator: Katharine Phillips, MD |
Principal Investigator: | Sabine Wilhelm, PhD | Massachusetts General Hospital |
Principal Investigator: | Katharine Phillips, MD | Butler Hospital |
Responsible Party: | Massachusetts General Hospital/Harvard Medical School ( Sabine Wilhelm, PhD ) |
Study ID Numbers: | R01 MH72854, 2004-P-002305, DSIR 83-ATSO |
Study First Received: | September 6, 2005 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00149799 |
Health Authority: | United States: Federal Government |
Body Dysmorphic Disorder Escitalopram Lexapro BDD |
Hypochondriasis Anxiety Disorders Mental Disorders Dexetimide |
Somatoform Disorders Citalopram Serotonin |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |