Delirium Reduction With Ramelteon

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Delirium

In brief

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.

Key facts

Study ID

NCT05069428

Run by

Centennial Medical Center

People needed

506

Starts

2023-03-26

Expected to finish

2025-12-01

Last updated by the study team

2024-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medical or surgical ICU patient
• Ability to take oral or nasogastric tube within 48 hours of admission to ICU
• Expected ICU length of stay and life expectancy at least 48 hours
• Patient or POA capable of signing informed consent within 48 hours of ICU admission

You may not qualify if…

• Past medical history includes cirrhosis
• Active alcohol withdrawal
• Patients taking fluvoxamine prior to admission
• Self-reported hypersensitivity to ramelteon
• Incarcerated patients
• Pregnant patients
• Patients with acute neurological conditions including brain abscess, head bleed, meningitis
• Patients who are transferred from an outside hospital where they have resided for greater than 4 days
• Non-English speaking patients
• Hearing-impaired patients requiring sign language for communication
• Visually-impaired patients

Where it is running

• Centennial Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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