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Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00265109
First received: December 12, 2005
Last updated: November 16, 2010
Last verified: November 2010
History of Changes

December 12, 2005
November 16, 2010
December 2004
January 2008   (final data collection date for primary outcome measure)
Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) [ Time Frame: Baseline to end week 12 ] [ Designated as safety issue: No ]
The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0-48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.
Yale Brown Obsessive-Compulsive Scale for BDD; Body Dysmorphic Disorder Clinical Global Impressions Scale
Complete list of historical versions of study NCT00265109 on ClinicalTrials.gov Archive Site
Body Dysmorphic Disorder Clinical Global Impressions Scale; Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory; [ Time Frame: Past week ] [ Designated as safety issue: Yes ]
Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory;
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Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Open-Label Study of Levetiracetam in Body Dysmorphic Disorder
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with 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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Body Dysmorphic Disorder
Drug: Levetiracetam
The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00265109
0410-001
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Katharine Phillips, MD, Rhode Island Hospital
Butler Hospital
UCB Pharma
Principal Investigator: Katharine A Phillips, M.D. Rhode Island Hospital/ Brown University
Butler Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP