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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00612859
First received: January 14, 2008
Last updated: November 25, 2013
Last verified: September 2009
  Purpose

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 Intervention Phase
Anxiety Disorders
Drug: levetiracetam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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.

Enrollment: 217
Study Start Date: September 2003
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612859

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00612859     History of Changes
Other Study ID Numbers: N01086
Study First Received: January 14, 2008
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014