Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Studies in humans and animals support that stress and/or elevations in corticosteroids lead to changes in hippocampal structure and functioning. This is important as patients with major depression frequently have elevated cortisol, and millions of patients receive prescription corticosteroids (e.g. prednisone). Both depression and corticosteroid therapy are associated with memory impairment and hippocampal atrophy. Our research uses corticosteroid-treated patients to explore interventions that might protect the brain from the effects of stress or corticosteroids. We propose to give 30 corticosteroid-treated asthma patients acetaminophen or placebo. Between group differences in mood, memory and other neurocognitive measures will serve as outcome measures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Acetaminophen; Prednisone

Criteria

Inclusion Criteria:

• Age 18-65

• Scheduled to receive at least 20 mg/day of prednisone for at least 7 days

• Baseline Rey Auditory Verbal Learning Test (RAVLT) total score of ≥40

Exclusion Criteria:

• History of allergic reaction or other contraindication to acetaminophen therapy

• Acetaminophen use within 24 hours of study entry

• History of liver disease or alcohol use of greater than 3 drinks/day

• Severe or unstable medical condition (e.g., recent myocardial infarction,renal failure, diabetes with poor glycemic control)

• Pregnant or lactating female

• Patient has mental retardation, dementia, or other severe cognitive disorder