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Delirium Reduction With Ramelteon

NCT05069428 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2024-08-22

No results posted yet for this study

Summary

The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.

Conditions

  • Delirium

Interventions

DRUG

Ramelteon 8mg

administered crushed, orally at 20:30

Sponsors & Collaborators

  • Centennial Medical Center

    lead OTHER

Principal Investigators

  • Jennifer Johnson, MD · Centennial Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-26
Primary Completion
2025-03-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069428 on ClinicalTrials.gov