Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive substance). This research also seeks to determine if patients taking phenytoin before corticosteroids show more activity in the area of the brain involved with memory than those receiving placebo.

This research is being done because increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with forgetfulness, and interventions that may prevent or reverse this effect are of great importance.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Neuroprotective Agents; Phenytoin

Criteria

Inclusion Criteria:

• Age 18-50 years

• Men or women

• Vision corrected to at least 20-40

• No tobacco use

• Education of ≥12 years (No GED)

Exclusion Criteria:

• History of major psychiatric illness defined as major depressive disorder, bipolar disorder, post traumatic stress disorder, panic disorder, schizoaffective disorder, schizophrenia or eating disorders

• History of drug or alcohol abuse or dependence

• History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease

• Taking central nervous system (CNS) acting medications (e.g. antidepressants, hypnotics)

• History of allergic reaction or medical contraindication to phenytoin or hydrocortisone therapy

• Metal implants, claustrophobia or other contraindications to MRI

• Significant medical conditions (e.g. myocardial infarction, diabetes)

• Pregnant or nursing women

• Prisoners

• History of mental retardation, special education classes, dementia or other severe cognitive disorders

• Baseline Hamilton Rating Scale for Depression Score > 7

• History of a suicide attempt

• History of systemic corticosteroid use or current inhaled corticosteroid use