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

Tracking Information

First Received Date ^ICMJE

December 12, 2005

Last Updated Date

November 16, 2010

Start Date ^ICMJE

December 2004

Primary Completion Date

January 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) [ Time Frame: Baseline to end week 12 ]

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.

Original Primary Outcome Measures ^ICMJE

Yale Brown Obsessive-Compulsive Scale for BDD; Body Dysmorphic Disorder Clinical Global Impressions Scale

Change History

Complete list of historical versions of study NCT00265109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory;

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Official Title ^ICMJE

Open-Label Study of Levetiracetam in Body Dysmorphic Disorder

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Body Dysmorphic Disorder

Intervention ^ICMJE

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.

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00265109

Other Study ID Numbers ^ICMJE

0410-001

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Katharine Phillips, MD, Rhode Island Hospital

Study Sponsor ^ICMJE

Butler Hospital

Collaborators ^ICMJE

UCB Pharma

Investigators ^ICMJE

Principal Investigator:

Katharine A Phillips, M.D.

Rhode Island Hospital/ Brown University

PRS Account

Butler Hospital

Verification Date

November 2010

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

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