Trial Outcomes & Findings for Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder (NCT NCT00265109)
NCT ID: NCT00265109
Last Updated: 2019-08-29
Results Overview
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.
COMPLETED
PHASE4
17 participants
Baseline to end week 12
2019-08-29
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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5
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Baseline characteristics by cohort
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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17 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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36.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Region of Enrollment
United States
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17 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to end week 12Population: Analyses of the primary outcome measure were intention to treat (ITT) analyses.
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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
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9 Participants
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SECONDARY outcome
Timeframe: Last week of treatment (week 12) or last week of treatment for early dropoutsThe 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms
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8 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.
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9 Participants
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SECONDARY outcome
Timeframe: Last week of treatment (week 12) or last week of treatment for early dropoutsThe 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms
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8 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.
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8 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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Scores on Brown Assessment of Beliefs Scale
Pre-treatment
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14.6 units on a scale
Standard Deviation 4.3
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Scores on Brown Assessment of Beliefs Scale
Post-treatment
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10.4 units on a scale
Standard Deviation 5.3
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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Scores on Clinical Global Severity
Post-treatment
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4.2 units on a scale
Standard Deviation 1.6
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Scores on Clinical Global Severity
Pre-treatment
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5.2 units on a scale
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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Scores on Hamilton Depression Rating Scale
Pre-treatment
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18.1 units on a scale
Standard Deviation 6.4
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Scores on Hamilton Depression Rating Scale
Post-treatment
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11.4 units on a scale
Standard Deviation 8.4
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Scores on Beck Anxiety Inventory
Pre-treatment
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12.4 units on a scale
Standard Deviation 6.8
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Scores on Beck Anxiety Inventory
Post-treatment
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9.6 units on a scale
Standard Deviation 5.5
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Scores on Social Phobia Inventory
Pre-treatment
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32.9 units on a scale
Standard Deviation 12.4
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Scores on Social Phobia Inventory
Post-treatment
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29.4 units on a scale
Standard Deviation 13.8
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SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Scores on Global Assessment of Functioning
Pre-treatment
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46.1 units on a scale
Standard Deviation 7.8
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Scores on Global Assessment of Functioning
Post-treatment
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55.8 units on a scale
Standard Deviation 14.5
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SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Scores on Social and Occupational Functioning Scale (SOFAS)
Post-treatment
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59.8 units on a scale
Standard Deviation 18.6
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Scores on Social and Occupational Functioning Scale (SOFAS)
Pre-treatment
|
47.0 units on a scale
Standard Deviation 8.5
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Open-Label Levetiracetam
n=17 Participants
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.
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|---|---|
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Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form
Pre-treatment
|
49.5 units on a scale
Standard Deviation 10.3
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Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form
Post-treatment
|
57.4 units on a scale
Standard Deviation 14.8
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Adverse Events
Open-Label Levetiracetam
Serious adverse events
| Measure |
Open-Label Levetiracetam
n=17 participants at risk
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.
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|---|---|
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Psychiatric disorders
Increased depression and suicidal ideation
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5.9%
1/17 • Number of events 1
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Other adverse events
| Measure |
Open-Label Levetiracetam
n=17 participants at risk
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.
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|---|---|
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Psychiatric disorders
Fatigue
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47.1%
8/17 • Number of events 8
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Psychiatric disorders
Irritability
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23.5%
4/17 • Number of events 4
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Psychiatric disorders
Insomnia
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23.5%
4/17 • Number of events 4
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Psychiatric disorders
Headache
|
17.6%
3/17 • Number of events 3
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Psychiatric disorders
Anxiety
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17.6%
3/17 • Number of events 3
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Psychiatric disorders
Nausea
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11.8%
2/17 • Number of events 2
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Psychiatric disorders
Dizziness
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11.8%
2/17 • Number of events 2
|
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Psychiatric disorders
Feelings of Detachment
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5.9%
1/17 • Number of events 1
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Psychiatric disorders
Agitation
|
5.9%
1/17 • Number of events 1
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|
Psychiatric disorders
Back Aches
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Constipation
|
5.9%
1/17 • Number of events 1
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|
Psychiatric disorders
Decreased Libido
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Diarrhea
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Forgetfulness
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Muscle Aches
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Feeling Depressed
|
5.9%
1/17 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place