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

Phase 4
Completed
Conditions
Memory Loss Associated With Corticosteroid Use
Manic State Associated With Corticosteroid Use
Registration Number
NCT00223223
Lead Sponsor
University of Texas Southwestern Medical Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The University of Texas Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

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