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Phase 3 Completed N=100 Randomized Double-blind Treatment

Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

Anxiety · Somatoform Disorders
Source: ClinicalTrials.gov NCT00149799 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: 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

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.

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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