Levetiracetam for Neuroprotection Against Corticosteroid-Induced Hippocampal Dysfunction: A Proof of Concept Study

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Texas Southwestern Medical Center UCB
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00223223

Purpose

The purpose of this research is to determine whether the memory impairment and manic symptoms (feelings of agitation, overexcitement or hyperactivity) typically seen in those on corticosteroid therapy is decreased with a seizure medication called levetiracetam compared to placebo (an inactive substance). Since increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with memory impairment interventions that may prevent or reverse this are of great importance.

It is hypothesized that patients who are scheduled to receive prescription corticosteroid therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic symptoms than those receiving placebo.

Condition	Intervention	Phase
Memory Loss Associated With Corticosteroid Use Manic State Associated With Corticosteroid Use	Drug: Levetiracetam, Keppra	Phase IV

MedlinePlus related topics: Memory

Drug Information available for: Corticosteroids Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Levetiracetam for Neuroprotection Against Corticosteroid-Induced Hippocampal Dysfunction: A Proof of Concept Study

Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment:	30
Study Start Date:	February 2005
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-65 years
Scheduled to receive a corticosteroid "burst" of at least 10 mg of prednisone equivalents and for at least 5 days duration
English- or Spanish-speaking

Exclusion Criteria:

History of allergic reaction or other contraindication to levetiracetam therapy
Other unstable medical conditions (e.g. recent myocardial infarction, renal failure, diabetes with poor glycemic control)
Pregnant or nursing women
History of mental retardation, dementia or other severe cognitive disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223223

Locations

United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

UCB

Investigators

Principal Investigator:

E. Sherwood Brown, M.D., Ph.D.

UT Southwestern Medical Center at Dallas

More Information

Study ID Numbers:	112004-003
Study First Received:	September 14, 2005
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00223223
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Neurologic Manifestations

Etiracetam
Psychotic Disorders
Neurobehavioral Manifestations
Memory Disorders
Amnesia

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Nervous System Diseases

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009