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

This study is currently recruiting participants.
Verified by University of Texas Southwestern Medical Center, January 2008

Sponsors and Collaborators: University of Texas Southwestern Medical Center
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00377364
  Purpose

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.


Condition Intervention Phase
Asthma
Rheumatic Disease
Drug: Acetaminophen
Phase IV

MedlinePlus related topics:   Asthma    Memory   

Drug Information available for:   Prednisone    Corticosteroids    Acetaminophen   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Acetaminophen for Mood and Memory Changes Associated With Prednisone Therapy

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment:   30
Study Start Date:   November 2006

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age 18-65
  • Scheduled to receive at least 20 mg/day of prednisone for at least 7 days
  • Baseline 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377364

Contacts
Contact: Daren Denniston, B.A.     214-645-6963     daren.denniston@utsouthwestern.edu    
Contact: Kaycie Kuss, B.S.     214-645-6953     Kaycie.Kuss@utsouthwestern.edu    

Locations
United States, Texas
UT Southwestern Medical Center at Dallas     Recruiting
      Dallas, Texas, United States, 75390
      Principal Investigator: Edson S Brown, M.D., PhD            

Sponsors and Collaborators
University of Texas Southwestern Medical Center
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Investigators
Principal Investigator:     Edson S Brown, M.D., PhD     UT Southwestern Medical Center at Dallas    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   022006-009
First Received:   September 14, 2006
Last Updated:   January 30, 2008
ClinicalTrials.gov Identifier:   NCT00377364
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Acetaminophen  
corticosteroids  
prednisone  

Study placed in the following topic categories:
Prednisone
Musculoskeletal Diseases
Connective Tissue Diseases
Asthma
Rheumatic Diseases
Acetaminophen

Additional relevant MeSH terms:
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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