Phase 4
N=30
Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy
Asthma · Rheumatic Disease
Bottom Line
View on ClinicalTrials.gov: NCT00377364 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Rey Auditory Verbal Learning Test (RAVLT) — 44.8; 44.1 words
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Drug: Acetaminophen, Drug: Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rey Auditory Verbal Learning Test (RAVLT) |
44.8; 44.1 | — |
| PRIMARY Rey Auditory Verbal Learning Task (RAVLT) |
44.9; 44.9 | <0.05 sig |
| PRIMARY Hamilton Rating Scale for Depression (HRSD-17) |
8.3; 10.3 | <0.05 sig |
| PRIMARY Hamilton Rating Scale for Depression (HRSD-17) |
8.3; 10.3 | <0.05 sig |
| PRIMARY Young Mania Rating Scale (YMRS) |
5.9; 5.6 | 0.05 |
| PRIMARY Young Mania Rating Scale (YMRS) |
5.9; 5.6 | 0.05 |
| SECONDARY Internal State Scale - Activation (ISS-ACT) |
93.5; 107.8 | <0.05 sig |
| SECONDARY Internal State Scale - Activation (ISS-ACT) |
93.5; 107.8 | <0.05 sig |
| SECONDARY Asthma Control Questionnaire (ACQ) |
3.1; 3.3 | — |
| SECONDARY Asthma Control Questionnaire |
1.9; 1.7 | <0.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00377364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.