CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Escitalopram +1 moredrug
Likely dose
Escitalopram at same dose as Phase I open-label treatment (specific dose not stated)AI-extracted
Key inclusion· 6
  • ✓Age 18 or older
  • ✓Diagnosis of body dysmorphic disorder (BDD) per DSM-IV criteria within 6 months of study start
  • ✓BDD severity score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale
  • ✓Outpatient status
Key exclusion· 2
  • ✕Suicidal or homicidal tendencies
  • ✕Alcohol or drug abuse/dependence within 3 months of study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00149799
NCT00149799Phase 3Completed
CompareCT.gov

Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder

Massachusetts General Hospital·interventional·Posted Sep 8, 2005·Updated Dec 5, 2017

In Brief

A Phase 3 clinical trial evaluating Escitalopram and Placebo for Anxiety Disorders and Somatoform Disorders. Completed, enrolled 100 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety Disorders, Somatoform Disorders
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Rhode Island Hospital

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartMay 1, 2005
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.8 years ago

Interventions

Escitalopramdrug

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.

Placebodrug

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.