Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
|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|
- Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS) [ Time Frame: Phase II: Biweekly for six months after randomization ] [ Designated as safety issue: No ]We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
- Phase I Response to Escitalopram (as Measured by the BDD-YBOCS) [ Time Frame: Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14 ] [ Designated as safety issue: No ]We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.
- Q-LES-Q Short Form [ Time Frame: Measured four times throughout study (Weeks 0, 14, 28, and 40) ] [ Designated as safety issue: No ]
- Psychosocial Functioning (as Measured by the LIFE-RIFT) [ Time Frame: Measured four times throughout study (Weeks 0, 14, 28, and 40) ] [ Designated as safety issue: No ]
- Depressive Symptoms (as Measured by the HAM-D) [ Time Frame: Measured biweekly for six months after randomization ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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)
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.
Other Name: Lexapro
Placebo Comparator: 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)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149799
|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 (MGH)|
|Principal Investigator:||Katharine Phillips, MD||Rhode Island Hospital (RIH)|