Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Open-Label Study of Levetiracetam in Body Dysmorphic Disorder

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

Study Overview

• Status: Completed
• Conditions: Body Dysmorphic Disorder
• Intervention / Treatment: Drug: Levetiracetam

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
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital Body Dysmorphic Disorder Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: open label; Open-label trial; all participants received levetiracetam

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms	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.	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.	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.	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	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.	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.	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.	Last week of treatment (week 12)
Scores on Brown Assessment of Beliefs Scale	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.	Pre- and post-treatment (week 12)
Scores on Clinical Global Severity	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).	Pre- and post-treatment (week 12)
Scores on Hamilton Depression Rating Scale	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.	Pre- and post-treatment (week 12)
Scores on Beck Anxiety Inventory	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.	Pre- and post-treatment (week 12)
Scores on Social Phobia Inventory	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.	Pre- and post-treatment (week 12)
Scores on Global Assessment of Functioning	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	Pre- and post-treatment (week 12)
Scores on Social and Occupational Functioning Scale (SOFAS)	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	Pre- and post-treatment (week 12)
Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form	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.	Pre- and post-treatment (week 12)

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: UCB Pharma
• Investigators: Principal Investigator: Katharine A Phillips, M.D., Rhode Island Hospital/ Brown University

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 12, 2005
• First Submitted That Met QC Criteria: December 12, 2005
• First Posted (Estimate): December 14, 2005

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: body dysmorphic disorder; levetiracetam
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Somatoform Disorders; Disease; Body Dysmorphic Disorders; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: 0410-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No