Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00265109
First received: December 12, 2005
Last updated: November 16, 2010
Last verified: November 2010
Results First Received: October 18, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Body Dysmorphic Disorder
Intervention: Drug: Levetiracetam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Open-Label Levetiracetam  
STARTED     17  
COMPLETED     11  
NOT COMPLETED     6  
Withdrawal by Subject                 5  
Adverse Event                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Baseline Measures
    Open-Label Levetiracetam  
Number of Participants  
[units: participants]
  17  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.8  ± 10.2  
Gender  
[units: participants]
 
Female     11  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures

1.  Primary:   Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)   [ Time Frame: Baseline to end week 12 ]

2.  Secondary:   Body Dysmorphic Disorder Clinical Global Impressions Scale; Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory;   [ Time Frame: Past week ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Katharine A. Phillips MD
Organization: Rhode Island Hospital Body Dysmorphic Disorder Program
phone: 401-444-1646
e-mail: katharine_phillips@brown.edu


No publications provided


Responsible Party: Katharine Phillips, MD, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00265109     History of Changes
Other Study ID Numbers: 0410-001
Study First Received: December 12, 2005
Results First Received: October 18, 2010
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board