Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Butler Hospital

Status and phase

Completed

Phase 4

Conditions

Body Dysmorphic Disorder

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00265109

0410-001

Details and patient eligibility

About

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

Full 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. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs); however, response to SRIs is often only partial. About one third of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI augmentation strategies are greatly needed.

Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. In the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in patients with BDD.

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.