Phase 3 N=100 Randomized Double-blind Treatment

Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

Anxiety Disorders · Somatoform Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00149799 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS) — 18; 40 percentage of subjects who relapsed — p=0.048

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Escitalopram (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)	18; 40	0.048 sig
SECONDARY Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)	67	—
SECONDARY Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)	3.5357143; 3.3793103; 3.8928571; 4.2333333; 5.2857143; 6.3703704	0.0930
SECONDARY Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)	9.0000000; 8.2413793; 9.8000000; 9.0000000; 9.7600000; 8.8947368	0.9766
SECONDARY Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)	74.1785714; 70.9259259; 70.2727273; 67.3684211; 69.0833333; 68.6470588	0.7724

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00149799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.