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Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

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ClinicalTrials.gov Identifier: NCT00265109
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : November 16, 2010
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Butler Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Body Dysmorphic Disorder
Intervention Drug: Levetiracetam
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 17
Completed 11
Not Completed 6
Reason Not Completed
Withdrawal by Subject             5
Adverse Event             1
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
36.8  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
11
  64.7%
Male
6
  35.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses of the primary outcome measure were intention to treat (ITT) analyses.
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
9
  52.9%
2.Secondary Outcome
Title Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Open-label trial; all participants received levetiracetam

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.

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
8
  47.1%
3.Secondary Outcome
Title Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Open-label trial; all participants received levetiracetam

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.

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
9
  52.9%
4.Secondary Outcome
Title Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Open-label trial; all participants received levetiracetam

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.

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
8
  47.1%
5.Secondary Outcome
Title Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label
Hide Arm/Group Description:

Open-label trial; all participants received levetiracetam

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.

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
8
  47.1%
6.Secondary Outcome
Title Scores on Brown Assessment of Beliefs Scale
Hide 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 Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 14.6  (4.3)
Post-treatment 10.4  (5.3)
7.Secondary Outcome
Title Scores on Clinical Global Severity
Hide Description 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).
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 5.2  (1.0)
Post-treatment 4.2  (1.6)
8.Secondary Outcome
Title Scores on Hamilton Depression Rating Scale
Hide Description 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.
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 18.1  (6.4)
Post-treatment 11.4  (8.4)
9.Secondary Outcome
Title Scores on Beck Anxiety Inventory
Hide Description 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.
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 12.4  (6.8)
Post-treatment 9.6  (5.5)
10.Secondary Outcome
Title Scores on Social Phobia Inventory
Hide Description 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.
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 32.9  (12.4)
Post-treatment 29.4  (13.8)
11.Secondary Outcome
Title Scores on Global Assessment of Functioning
Hide Description 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
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 46.1  (7.8)
Post-treatment 55.8  (14.5)
12.Secondary Outcome
Title Scores on Social and Occupational Functioning Scale (SOFAS)
Hide Description 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
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 47.0  (8.5)
Post-treatment 59.8  (18.6)
13.Secondary Outcome
Title Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form
Hide Description 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.
Time Frame Pre- and post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 49.5  (10.3)
Post-treatment 57.4  (14.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label Levetiracetam
Hide Arm/Group Description 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.
All-Cause Mortality
Open-Label Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label Levetiracetam
Affected / at Risk (%) # Events
Total   1/17 (5.88%)    
Psychiatric disorders   
Increased depression and suicidal ideation  1/17 (5.88%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-Label Levetiracetam
Affected / at Risk (%) # Events
Total   12/17 (70.59%)    
Psychiatric disorders   
Fatigue   8/17 (47.06%)  8
Irritability   4/17 (23.53%)  4
Insomnia   4/17 (23.53%)  4
Headache   3/17 (17.65%)  3
Anxiety   3/17 (17.65%)  3
Nausea   2/17 (11.76%)  2
Dizziness   2/17 (11.76%)  2
Feelings of Detachment   1/17 (5.88%)  1
Agitation   1/17 (5.88%)  1
Back Aches   1/17 (5.88%)  1
Constipation   1/17 (5.88%)  1
Decreased Libido   1/17 (5.88%)  1
Diarrhea   1/17 (5.88%)  1
Dyspepsia   1/17 (5.88%)  1
Forgetfulness   1/17 (5.88%)  1
Muscle Aches   1/17 (5.88%)  1
Feeling Depressed   1/17 (5.88%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katharine A. Phillips MD
Organization: Weill Cornell Medicine
Phone: 646-962-2820
EMail: kap9161@med.cornell.edu
Layout table for additonal information
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00265109     History of Changes
Other Study ID Numbers: 0410-001
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: October 18, 2010
Results First Posted: November 16, 2010
Last Update Posted: August 29, 2019