Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
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ClinicalTrials.gov Identifier: NCT00265109 |
Recruitment Status :
Completed
First Posted : December 14, 2005
Results First Posted : November 16, 2010
Last Update Posted : August 29, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | December 12, 2005 | |||
First Posted Date ICMJE | December 14, 2005 | |||
Results First Submitted Date ICMJE | October 18, 2010 | |||
Results First Posted Date ICMJE | November 16, 2010 | |||
Last Update Posted Date | August 29, 2019 | |||
Study Start Date ICMJE | December 2004 | |||
Actual 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.
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Original Primary Outcome Measures ICMJE |
Yale Brown Obsessive-Compulsive Scale for BDD; Body Dysmorphic Disorder Clinical Global Impressions Scale | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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 Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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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.
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Study Arms ICMJE | open label
Open-label trial; all participants received levetiracetam
Intervention: Drug: Levetiracetam
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
17 | |||
Original Enrollment ICMJE |
15 | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
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 | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Butler Hospital | |||
Study Sponsor ICMJE | Butler Hospital | |||
Collaborators ICMJE | UCB Pharma | |||
Investigators ICMJE |
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PRS Account | Butler Hospital | |||
Verification Date | August 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |