Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Levetiracetam

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder focused on measuring body dysmorphic disorder, levetiracetam

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rhode Island Hospital Body Dysmorphic Disorder Program

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open label

Arm Description

Open-label trial; all participants received levetiracetam

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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).

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.

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.

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.

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

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

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.

Full Information

NCT ID

NCT00265109

First Posted

December 12, 2005

Last Updated

August 27, 2019

Sponsor

Butler Hospital

Collaborators

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00265109

Brief Title

Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Official Title

Open-Label Study of Levetiracetam in Body Dysmorphic Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Butler Hospital

Collaborators

UCB Pharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Dysmorphic Disorder

Keywords

body dysmorphic disorder, levetiracetam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

open label

Arm Type

Other

Arm Description

Open-label trial; all participants received levetiracetam

Intervention Type

Drug

Intervention Name(s)

Levetiracetam

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)

Description

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.

Time Frame

Baseline to end week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms

Description

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.

Time Frame

Last week of treatment (week 12) or last week of treatment for early dropouts

Title

Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.

Description

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.

Time Frame

Last week of treatment (week 12)

Title

Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms

Description

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.

Time Frame

Last week of treatment (week 12) or last week of treatment for early dropouts

Title

Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.

Description

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.

Time Frame

Last week of treatment (week 12)

Title

Scores on Brown Assessment of Beliefs Scale

Description

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.

Time Frame