Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Last updated: August 27, 2019
Sponsor: Butler Hospital
Overall Status: Completed

Phase

4

Condition

Bulimia

Anxiety Disorders

Body Dysmorphic Disorder

Treatment

N/A

Clinical Study ID

NCT00265109
0410-001
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women age 18-65;

  • Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) forat least 3 months;

  • A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified forBDD (BDD-YBOCS) (19);

  • Suitable for treatment in an outpatient setting

Exclusion

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 childbearingpotential;

  • A need for prn benzodiazepines, another antiepileptic medication, or an anticipatedchange in the dose of any concomitant medications while receiving treatment withlevetiracetam;

  • Clinically significant suicidality, including a suicide attempt within the past twomonths;

  • Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychoticdisorder 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 monthsprior 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.

Study Design

Total Participants: 17
Study Start date:
December 01, 2004
Estimated Completion Date:
January 31, 2008

Study 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.

Connect with a study center

  • Rhode Island Hospital Body Dysmorphic Disorder Program

    Providence, Rhode Island 02903
    United States

    Site Not Available

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