NCT Number: NCT00612859
Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)
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.
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
UCB Pharma
Industry
Registry information
Official study title
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)
Important dates
- Study start
- 2003
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Feb 12, 2008
- Registry last updated
- Nov 26, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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