Manic State Associated With Corticosteroid Use, Memory Loss Associated With Corticosteroid Use
Conditions
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.
Interventions
DRUGLevetiracetam, Keppra
Sponsors
UCB Pharma
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed