CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Drug: Acetaminophen, Drug: Placebodrug
Likely dose
Drug: Acetaminophen, Drug: Placebo 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00377364
NCT00377364Phase 4Completed

Acetaminophen for Mood and Memory Changes Associated With Prednisone Therapy

University of Texas Southwestern Medical Center·interventional·Posted Sep 18, 2006·Updated May 5, 2016

In Brief

A Phase 4 clinical trial evaluating Drug: Acetaminophen, Drug: Placebo for Asthma and Rheumatic Disease. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2006
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.8 years ago

Interventions

Drug: Acetaminophen, Drug: Placebodrug

Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days