Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)
A Multicenter, Randomized, Double-Blind, PBO-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Levetiracetam Versus PBO for the Treatment of Social Anxiety Disorder (Generalized Type)
1 other identifier
interventional
217
0 countries
N/A
Brief Summary
Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is reason to believe that compounds with anxiolytic activity may have broad clinical utility across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with social anxiety disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2003
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 12, 2008
CompletedNovember 26, 2013
September 1, 2009
9 months
January 14, 2008
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in Liebowitz Social Anxiety Scale (LSAS) score from Visit 2 to the last Evaluation period visit attended using last observation carried forward (LOCF) methods
Safety: monitoring of AEs, clinical laboratory tests, physical examination and vital signs.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female outpatients between 18 and 70 years old inclusive;
- symptoms of social anxiety disorders (generalized type) present for at least 1 year prior to Selection Visit;
- had a score of \>=60 on the LSAS at the Selection Visit and at the Randomization Visit. Additionally, the clinician's gloal impression of change score must have been \>= 2 at the Randomization Visit;
- had a telephone where they could be directly contacted.
You may not qualify if:
- History of autism or Asperger's Disease;
- had another primary axis I disorder or fulfilled diagnostic and statistical manual of mental disorders-4th edition (DSM-IV) criteria in the 6 months prior to Screening;
- major depression as measured by a Hamilton Depression Rating Scale (HAM-D-17 items) total score of \> 17 and/or a suicide subscale score on the HAM-D-17 items of \> 2 at the Selection or Randomization Visit;
- history of electroconvulsive therapy within the prior 3 months;
- history of psychotherapy which was not stable and ongoing for at least 6 months prior to Visit 1;
- clinical history of significantly impaired renal function with an estimated creatinine clearance below 80 mL/min;
- clinically significant medical condition;
- history of any clinically significant allergic condition or allergy to LEV or pyrrolidone derivatives;
- neutrophil count of less than 1800/µL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 14, 2008
First Posted
February 12, 2008
Study Start
September 1, 2003
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
November 26, 2013
Record last verified: 2009-09