Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
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Purpose
This study will assess the relapse-prevention rate of escitalopram (Lexapro) in the treatment of body dysmorphic disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders Somatoform Disorders |
Drug: Escitalopram Drug: Placebo Drug: Escitalopram extension |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder |
- Relapse of Body Dysmorphic Disorder Symptoms (as measured by the BDD-YBOCS) [ Time Frame: Biweekly for six months after randomization ] [ Designated as safety issue: No ]
- Functioning and life satisfaction (as measured by the LIFE) [ Time Frame: Measured four times throughout study (Screening, EW14, EW28 and EW40) ] [ Designated as safety issue: No ]
- Depressive symptoms (as measured by the BDI-II) [ Time Frame: Measured biweekly for six months after randomization ] [ Designated as safety issue: No ]
- Anxiety symptoms (as measured by the SIGH-D) [ Time Frame: Measured at every study visit for 40 weeks ] [ Designated as safety issue: No ]
- Delusionality of BDD symptoms (as measured by the BABS) [ Time Frame: Measured at every study visit for 40 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | May 2005 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Escitalopram
Participants taking Escitalopram only for both Phase I and Phase II of the trial
|
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.
Other Name: Lexapro
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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|
Placebo Comparator: Placebo
Participants taking Escitalopram for Phase I of the study (Weeks 1-14) followed by a placebo for Phase II of the study (Weeks 16-40)
|
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.
Other Name: Lexapro
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Outpatient men and women age 18 and older
- DSM-IV diagnosis of BDD within 6 months of study start date
- 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
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| Principal Investigator: | Sabine Wilhelm, PhD | Massachusetts General Hospital |
| Principal Investigator: | Katharine Phillips, MD | Butler Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sabine Wilhelm, PhD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00149799 History of Changes |
| Other Study ID Numbers: | R01 MH072854, R01MH072854, 2004-P-002305, DSIR 83-ATSO |
| Study First Received: | September 6, 2005 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
Body Dysmorphic Disorder Escitalopram Lexapro BDD Body Image |
Additional relevant MeSH terms:
|
Anxiety Disorders Body Dysmorphic Disorders Somatoform Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 21, 2013