Clinical Trials Directory

Trials / Terminated

TerminatedNCT00211809

CBT as an Adjunct to SRIs in the Treatment of BDD

A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
16 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment

Detailed description

In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral Therapystandard psychiatric evaluation
DRUGVenlafaxinestart dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.

Timeline

Start date
2008-09-01
Primary completion
2009-06-01
Completion
2009-06-01
First posted
2005-09-21
Last updated
2017-03-09
Results posted
2017-03-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00211809. Inclusion in this directory is not an endorsement.