Status:
COMPLETED
Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Lead Sponsor:
Butler Hospital
Collaborating Sponsors:
UCB Pharma
Conditions:
Body Dysmorphic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.
Detailed Description
Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning....
Eligibility Criteria
Inclusion
- Men and women age 18-65;
- Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for at least 3 months;
- A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) (19);
- Suitable for treatment in an outpatient setting
Exclusion
- Unstable medical illness, including renal failure or dialysis;
- Myocardial infarction within 6 months;
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- A need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam;
- Clinically significant suicidality, including a suicide attempt within the past two months;
- Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic disorder that is not attributable to BDD;
- Current or recent (past 3 months) DSM-IV substance abuse or dependence;
- Initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline;
- Ongoing cognitive-behavioral therapy from a mental health professional;
- Previous treatment with levetiracetam;
- Treatment with investigational medication, depot neuroleptics, or ECT within the past 3 months.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00265109
Start Date
December 1 2004
End Date
January 1 2008
Last Update
August 29 2019
Active Locations (1)
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1
Rhode Island Hospital Body Dysmorphic Disorder Program
Providence, Rhode Island, United States, 02903