Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

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.

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.