Status:
COMPLETED
Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Asthma
Rheumatic Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 fre...
Detailed Description
SCIENTIFIC PROPOSAL Aims Primary 1. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller declines in declarative memory than those receiving p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00377364
Start Date
November 1 2006
End Date
October 1 2008
Last Update
May 5 2016
Active Locations (1)
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1
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390