Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Butler Hospital
• Collaborator: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.