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Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

Primary Purpose

Anxiety Disorders, Somatoform Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Body Dysmorphic Disorder, Escitalopram, Lexapro, BDD, Body Image

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Escitalopram

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 6, 2005
Last Updated
November 30, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH), Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00149799
Brief Title
Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
Official Title
Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH), Rhode Island Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Somatoform Disorders
Keywords
Body Dysmorphic Disorder, Escitalopram, Lexapro, BDD, Body Image

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
Description
We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
Time Frame
Phase II: Biweekly for six months after randomization
Secondary Outcome Measure Information:
Title
Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
Description
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.
Time Frame
Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14
Title
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Description
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.
Time Frame
Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40
Title
Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Description
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.
Time Frame
Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)
Title
Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Description
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.
Time Frame
Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital (MGH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katharine Phillips, MD
Organizational Affiliation
Rhode Island Hospital (RIH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31505519
Citation
Fang A, Porth R, Phillips KA, Wilhelm S. Personality as a Predictor of Treatment Response to Escitalopram in Adults With Body Dysmorphic Disorder. J Psychiatr Pract. 2019 Sep;25(5):347-357. doi: 10.1097/PRA.0000000000000415.
Results Reference
derived
PubMed Identifier
29557815
Citation
Weingarden H, Shaw AM, Phillips KA, Wilhelm S. Shame and Defectiveness Beliefs in Treatment Seeking Patients With Body Dysmorphic Disorder. J Nerv Ment Dis. 2018 Jun;206(6):417-422. doi: 10.1097/NMD.0000000000000808.
Results Reference
derived
Links:
URL
http://www.mghocd.org/bdd
Description
Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH

Learn more about this trial

Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

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