Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
|ClinicalTrials.gov Identifier: NCT00265109|
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : November 16, 2010
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Body Dysmorphic Disorder||Drug: Levetiracetam||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study of Levetiracetam in Body Dysmorphic Disorder|
|Study Start Date :||December 2004|
|Primary Completion Date :||January 2008|
|Study Completion Date :||January 2008|
Open-label trial; all participants received 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 Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265109
|United States, Rhode Island|
|Rhode Island Hospital Body Dysmorphic Disorder Program|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Katharine A Phillips, M.D.||Rhode Island Hospital/ Brown University|