Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Open-Label Study of Levetiracetam in Body Dysmorphic Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265109

Enrollment

Registered

2005-12-14

Start date

2004-12-31

Completion date

2008-01-31

Last updated

2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Dysmorphic Disorder

Keywords

body dysmorphic disorder, levetiracetam

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.

Interventions

DRUGLevetiracetam

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 Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.	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	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.	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	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	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).
Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms	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.
Scores on Beck Anxiety Inventory	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	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	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)	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	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.
Scores on Hamilton Depression Rating Scale	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Open-Label Levetiracetam All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.	17
Total	17

Arm

Count

Open-Label Levetiracetam

All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Withdrawal by Subject	5

Baseline characteristics

Characteristic	Open-Label Levetiracetam
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	17 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 10.2
Region of Enrollment United States	17 participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	12 / 17
serious Total, serious adverse events	1 / 17

Outcome results

Primary

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.

Time frame: Baseline to end week 12

Population: Analyses of the primary outcome measure were intention to treat (ITT) analyses.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Open-Label Levetiracetam	Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)	9 Participants

Secondary

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.

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Open-Label Levetiracetam	Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms	8 Participants

Secondary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Open-Label Levetiracetam	Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms	8 Participants

Secondary

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.

Time frame: Last week of treatment (week 12)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Open-Label Levetiracetam	Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.	9 Participants

Secondary

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)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Open-Label Levetiracetam	Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.	8 Participants

Secondary

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.