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NCT00377364 · ClinicalTrials.gov registry record · Phase 4
Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00377364: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT00377364 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377364, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words
Interventions
- DRUG Drug: Acetaminophen, Drug: Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
What the finished NCT00377364 record still lists
NCT00377364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Drug: Acetaminophen, Drug: Placebo is the first listed.
NCT00377364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00377364 about?
NCT00377364 is a clinical study titled "Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy". 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. ...
What is the current status of trial NCT00377364?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2006-11. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00377364?
The interventions under investigation include: Drug: Acetaminophen, Drug: Placebo (DRUG).
Who is sponsoring clinical trial NCT00377364?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00377364's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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