drugset / Trial / NCT00377364

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

NCT00377364 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2006-11
Primary completion
2008-10
Completion
2008-10

Outcome

Mixed primary results

registry MEAN Acetaminophen: 8.3 (Standard Deviation 6.5) units on a scale MEAN Placebo: 10.3 (Standard Deviation 8.4) units on a scale NCT00377364 ↗

registry analysis (superiority or other test); Acetaminophen vs Placebo; p <0.05; ANCOVA NCT00377364 ↗

registry MEAN Acetaminophen: 5.9 (Standard Deviation 5.8) units on a scale MEAN Placebo: 5.6 (Standard Deviation 5.4) units on a scale NCT00377364 ↗

registry analysis (superiority or other test); Acetaminophen vs Placebo; p = 0.05; ANCOVA NCT00377364 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg —