Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

NCT00149799 | Completed Phase 3 Results DMC

• 3 other identifiers: R01MH0728542004-P-002305DSIR 83-ATSO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety Disorders; Somatoform Disorders

Keywords

Body Dysmorphic Disorder; Escitalopram; Lexapro; BDD; Body Image

Outcome Measures

Primary Outcomes (1)

• 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.

  Phase II: Biweekly for six months after randomization

Secondary Outcomes (4)

• Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)

  Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14

• Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)

  Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40

• Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)

  Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

• Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)

  Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

Study Arms (2)

Escitalopram

EXPERIMENTAL

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)

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suicidal or homicidal tendencies
• Alcohol/drug abuse or dependence within 3 months of study entry

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Rhode Island Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

• 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.

  PMID: 31505519 DERIVED

• 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.

  PMID: 29557815 DERIVED

Related Links

• Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH

MeSH Terms

Conditions

Anxiety Disorders; Somatoform Disorders; Body Dysmorphic Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Our findings may not be fully generalizable - for example, we excluded those with a co-occurring substance use disorder, higher levels of suicidality, and more severely ill patients who required concomitant therapy or a higher level of care.

Results Point of Contact

• Title: Katharine A. Phillips, MD
• Organization: Rhode Island Hospital

katharine_phillips@brown.edu

401-444-1646

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital (MGH)

  PRINCIPAL INVESTIGATOR

• Katharine Phillips, MD

  Rhode Island Hospital (RIH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 5, 2017
• Results First Posted: November 21, 2014

Record last verified: 2017-11

Locations

US (2)