Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

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

Detailed Description
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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.

Official Title
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Open-Label Study of Levetiracetam in Body Dysmorphic Disorder

Conditions
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Body Dysmorphic Disorder

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open label<br>Open-label trial; all participants received levetiracetam | Drug: Levetiracetam<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body dysmorphic disorder, levetiracetam