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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00612859

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 II

MedlinePlus related topics: Anxiety

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by UCB:

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

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

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Study ID Numbers:	N01086
Study First Received:	January 14, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00612859
Health Authority:	United States: Institutional Review Board

Keywords provided by UCB:

Levetiracetam
Keppra

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Piracetam
Etiracetam
Phobic Disorders

Additional relevant MeSH terms:

Nootropic Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 13, 2009