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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612859

Enrollment

217

Registered

2008-02-12

Start date

2003-09-30

Completion date

2004-06-30

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Levetiracetam, Keppra

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.

Interventions

DRUGlevetiracetam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026