Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy
This study has been completed.
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
First received: September 14, 2006
Last updated: May 8, 2009
Last verified: May 2009
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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 4 |
| 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:
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:
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 May 16, 2013