Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

NCT00265109 | Completed Phase 4 Results

• 1 other identifier: 0410-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Body Dysmorphic Disorder

Keywords

body dysmorphic disorder; levetiracetam

Outcome Measures

Primary Outcomes (1)

• Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)

  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.

  Baseline to end week 12

Secondary Outcomes (12)

• Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms

  Last week of treatment (week 12) or last week of treatment for early dropouts

• Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.

  Last week of treatment (week 12)

• Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms

  Last week of treatment (week 12) or last week of treatment for early dropouts

• Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.

  Last week of treatment (week 12)

• Scores on Brown Assessment of Beliefs Scale

  Pre- and post-treatment (week 12)

Study Arms (1)

open label

OTHER

Open-label trial; all participants received levetiracetam

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

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.

open label

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• UCB Pharma: collaborator

Study Sites (1)

Rhode Island Hospital Body Dysmorphic Disorder Program

Providence, Rhode Island, 02903, United States

Location

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This is a small open-label trial.

Results Point of Contact

• Title: Katharine A. Phillips MD
• Organization: Weill Cornell Medicine

kap9161@med.cornell.edu

646-962-2820

Study Officials

• Katharine A Phillips, M.D.

  Rhode Island Hospital/ Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Study Start: December 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 29, 2019
• Results First Posted: November 16, 2010

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)