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: August 29, 2019
• Sponsor: Butler Hospital
• Collaborator: UCB Pharma
• Information provided by (Responsible Party): Butler Hospital

Tracking Information

• First Submitted Date: December 12, 2005
• First Posted Date: December 14, 2005
• Results First Submitted Date: October 18, 2010
• Results First Posted Date: November 16, 2010
• Last Update Posted Date: August 29, 2019
• Study Start Date: December 2004
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: December 12, 2005): Yale Brown Obsessive-Compulsive Scale for BDD; Body Dysmorphic Disorder Clinical Global Impressions Scale

Current Secondary Outcome Measures (submitted: August 27, 2019)

• Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms [ Time Frame: Last week of treatment (week 12) or last week of treatment for early dropouts ]
  The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD.
• Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement. [ Time Frame: Last week of treatment (week 12) ]
  The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement.
• Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms [ Time Frame: Last week of treatment (week 12) or last week of treatment for early dropouts ]
  The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD.
• Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement. [ Time Frame: Last week of treatment (week 12) ]
  The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement.
• Scores on Brown Assessment of Beliefs Scale [ Time Frame: Pre- and post-treatment (week 12) ]
  The Brown Assessment of Beliefs Scale (BABS) is a 7-item semi-structured clinician-administered scale that assesses seven components of delusionality (insight) during the past week. Scores range from 0-24, with higher scores indicating greater delusionality. Beliefs are also categorized as delusional or nondelusional using an empirically derived cutpoint.
• Scores on Clinical Global Severity [ Time Frame: Pre- and post-treatment (week 12) ]
  The 7-point Clinical Global Severity Scale assessed current illness severity at study baseline (score of 1=normal, not at all ill, and score of 7=among the most extremely ill patients).
• Scores on Hamilton Depression Rating Scale [ Time Frame: Pre- and post-treatment (week 12) ]
  The 24-item Hamilton Rating Scale for Depression (HAM-D 24) is a widely used reliable and valid clinician-administered measure of current severity of depressive symptoms. Scores range from 0 to 76, with higher scores reflecting more severe depressive symptoms.
• Scores on Beck Anxiety Inventory [ Time Frame: Pre- and post-treatment (week 12) ]
  The Beck Anxiety Inventory (BAI) is a reliable, valid, and widely used 21-item self-report measure of anxiety during the past week which focuses on somatic symptoms.44 The BAI has been shown to be sensitive to change. Scores range from 0-63, with higher scores reflecting more severe symptoms.
• Scores on Social Phobia Inventory [ Time Frame: Pre- and post-treatment (week 12) ]
  The Social Phobia Inventory (SPIN) is a 17-item self-report questionnaire that assesses fear, avoidance, and physiological arousal associated with social anxiety during the past week. This scale is reliable, valid, and sensitive to change. Scores range from 0-68, with a score ≥19 distinguishing patients with social phobia from both healthy controls and psychiatric controls without social phobia.
• Scores on Global Assessment of Functioning [ Time Frame: Pre- and post-treatment (week 12) ]
  The Global Assessment of Functioning (GAF) is a global measure of symptom severity and psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning
• Scores on Social and Occupational Functioning Scale (SOFAS) [ Time Frame: Pre- and post-treatment (week 12) ]
  The Social and Occupational Functioning Scale (SOFAS) is a global measure of psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning
• Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form [ Time Frame: Pre- and post-treatment (week 12) ]
  The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Short Form, is a 14-item reliable and valid measure that is sensitive to change. Transformed scores range from 0 from 100, with lower scores reflecting poorer quality of life.The Short Form transformed score is reported.

• Original Secondary Outcome Measures (submitted: December 12, 2005): 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: Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Body Dysmorphic Disorder

Intervention

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 18, 2010): 17
• Original Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00265109
• Other Study ID Numbers: 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: Butler Hospital
• Collaborators: UCB Pharma

Investigators

• Principal Investigator: Katharine A Phillips, M.D.; Rhode Island Hospital/ Brown University

• PRS Account: Butler Hospital
• Verification Date: August 2019