Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

Study Overview
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Brief Summary
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This study's 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.

Detailed Description
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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.

Official Title
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Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

Conditions
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Anxiety Disorders, Somatoform Disorders

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient men and women age 18 and older 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: Suicidal or homicidal tendencies Alcohol/drug abuse or dependence within 3 months of study entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>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) | Drug: Escitalopram<br>* 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.<br>* Other names: Lexapro;|
| Placebo Comparator: Placebo<br>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) | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS) | We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II. | Phase II: Biweekly for six months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I Response to Escitalopram (as Measured by the BDD-YBOCS) | 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. | Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14 | 
| Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II) | Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression. | Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40 | 
| Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II) | Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning. | Measured three times throughout phase 2 of study (Weeks 14, 28 and 40) | 
| Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II) | Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction. | Measured three times throughout phase 2 of study (Weeks 14, 28 and 40) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lexapro, Body Dysmorphic Disorder, Escitalopram, BDD, Body Image