Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)

• ClinicalTrials.gov Identifier: NCT00612859
• Recruitment Status: Completed
• First Posted: February 12, 2008
• Last Update Posted: November 26, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders	Drug: levetiracetam	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official 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)
• Study Start Date: September 2003
• Actual Primary Completion Date: June 2004
• Actual Study Completion Date: June 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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
2. Safety: monitoring of AEs, clinical laboratory tests, physical examination and vital signs.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

• ClinicalTrials.gov Identifier: NCT00612859
• Other Study ID Numbers: N01086
• First Posted: February 12, 2008
• Last Update Posted: November 26, 2013
• Last Verified: September 2009

Keywords provided by UCB Pharma:

Levetiracetam; Keppra

Additional relevant MeSH terms:

Anxiety Disorders; Phobia, Social; Mental Disorders; Phobic Disorders; Levetiracetam; Anticonvulsants; Nootropic Agents