Overview

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.