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)

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Drug: levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): February 12, 2008

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Levetiracetam; Keppra
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01086