Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00612859
First received: January 14, 2008
Last updated: September 14, 2009
Last verified: September 2009
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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:
MedlinePlus related topics:
Anxiety
Drug Information available for:
Levetiracetam
U.S. FDA Resources
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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00612859 History of Changes |
| Other Study ID Numbers: | N01086 |
| Study First Received: | January 14, 2008 |
| Last Updated: | September 14, 2009 |
| 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 June 18, 2013