Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Tracking Information
First Submitted Date ICMJE	December 12, 2005
First Posted Date ICMJE	December 14, 2005
Results First Submitted Date	October 18, 2010
Results First Posted Date	November 16, 2010
Last Update Posted Date	May 15, 2018
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; (submitted: November 16, 2010)	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; (submitted: December 12, 2005)	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; (submitted: September 9, 2008)	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; (submitted: December 12, 2005)	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	Intervention Model: Single Group Assignment; Masking: None (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	open label; Open-label trial; all participants received levetiracetam; Intervention: Drug: Levetiracetam
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
Actual Enrollment ICMJE; (submitted: October 18, 2010)	17
Original Enrollment ICMJE; (submitted: December 12, 2005)	15
Actual Study Completion Date	January 2008
Actual 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, Older Adult)
Accepts Healthy Volunteers	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	Plan to Share IPD: No
Responsible Party	Butler 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	April 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP