Status:
TERMINATED
CBT as an Adjunct to SRIs in the Treatment of BDD
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Body Dysmorphic Disorder
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief 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 (...
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-...
Eligibility Criteria
Inclusion
- Age 16-65
- A diagnosis of DSM-IV BDD or its delusional variant (delusional disorder, somatic type)
- Ability to communicate meaningfully with the investigators
- Competent to provide written consent, if over 18 years old, or competent to provide written assent, if 16-17 years, 11 months
- Parental consent, if under 18 years old
- For phase two: must be on a stable therapeutic dose of one of the following SRI medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine, paroxetine, citalopram, or sertraline.
Exclusion
- current or lifetime diagnosis of any DSM\_IV psychotic disorder not attributable to delusional BDD, current or lifetime diagnosis of DSM-IV bipolar disorder,
- current or recent (within 2 months of study entry) DSM-IV alcohol or substance dependence or abuse,
- recent suicide attempt, or suicidal ideation that warrants consideration of hospitalization,
- need for inpatient or partial hospital treatment,
- use of any medication prescribed for the treatment of BDD other than SRIs, including tricyclic antidepressants, buspirone, or neuroleptics,
- presence of any significant and/or unstable medical condition,
- females who are pregnant or breast-feeding, or who are sexually active and not using adequate contraception.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00211809
Start Date
September 1 2008
End Date
June 1 2009
Last Update
March 9 2017
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574