Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy - Full Text View

Sponsor:	University of Texas Southwestern Medical Center
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Acetaminophen for Mood and Memory Changes Associated With Prednisone Therapy

Resource links provided by NLM:

MedlinePlus related topics: Asthma Memory

Drug Information available for: Prednisone Acetaminophen CT 2584 Corticosteroids

U.S. FDA Resources

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
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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

Locations

United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	E.S. Brown, UT Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00377364 History of Changes
Other Study ID Numbers:	022006-009
Study First Received:	September 14, 2006
Last Updated:	May 8, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Acetaminophen
corticosteroids
prednisone

Additional relevant MeSH terms:

Asthma
Rheumatic Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Acetaminophen
Prednisone
Antipyretics

Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012