Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Acetaminophen for Mood and Memory Changes Associated With Prednisone Therapy|
- Baseline demographic and clinical characteristics will be compared between treatment groups and characteristics showing clinically or statistically significant differences will be considered as covariates.
- All tests of hypotheses will be twotailed.
- Any participants with undetectable prednisone or prednisolone levels at exit will be judged to be nonadherent with this medication and excluded from the analysis.
- Intent to treat sample can be defined either as everyone who receives study drug or everyone who returns for at least one postbaseline visit.
- If they do not return for at least one postbaseline visit we will not have data on study drug (or on prednisone) for the analyses.
- Since we have two postbaseline visits, if we only tested those who come to both then that would be a completion analysis; therefore, we will use any participants who come to at least one postbaseline visit on medication (ITT sample) in the analysis.
- Given a small sample size we may not have statistical power to detect significant between group differences if the effect size is not large.
- However, this pilot study will provide the necessary information to power a larger, more definitive study funded by NIH.
|Study Start Date:||November 2006|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|United States, Texas|
|UT Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Edson S Brown, M.D., PhD||UT Southwestern Medical Center at Dallas|