Trial intelligence / Profile preview

Escitalopram Relapse Prevention in Body Dysmorphic Disorder

NCT00149799Phase 3

Key facts

Status: Completed
Start: May 2005
Primary completion: Mar 2013
Countries: 1
Sponsor: Massachusetts General Hospital
Modality: Small Molecules

Drugs: escitalopram
Conditions: body dysmorphic disorder (BDD)

Overview

Phase 3, randomised, double-blind trial in body dysmorphic disorder (BDD) comparing Escitalopram with Placebo (2 arms). Primary endpoint: Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms at 6 months. Started May 2005; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Escitalopram
Continuation of escitalopram treatment.
Placebo
Switch to placebo.

Who it enrols

Adult outpatients with a diagnosis of BDD (DSM-IV) and a BDD-YBOCS score of 24 or higher. Excludes patients with suicidal/homicidal tendencies or recent alcohol/drug abuse.

Endpoints

Primary

Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms6 months

Secondary

Phase I Response to Escitalopram14 weeks
Change in Depression Symptoms (HAM-D)Week 40
Change in Functional Impairment Symptoms (LIFE-RIFT)Week 40
Change in Quality of Life (Q-LES-Q-SF)Week 40

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