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Ramelteon for Delirium in the ICU

This study is looking at whether a medication called Ramelteon (which is approved for insomnia) can help prevent or treat delirium in patients in the intensive care unit (ICU). Delirium is a serious change in mental ability that can happen to people who are very sick. Researchers believe Ramelteon might help by regulating the body's natural sleep-wake cycle. The study will measure how many days patients are alive without delirium or coma in the ICU over 14 days. You might be able to join if you are an adult ICU patient, can take medicine by mouth or tube, and are expected to stay in the ICU for at least 48 hours. The current status of this study is unclear.

Study design
This study is interventional and plans to enroll 506 participants. It compares Ramelteon to a placebo (an inactive substance) to see its effect.
What's involved
Participants would receive Ramelteon 8mg, given as a crushed pill by mouth at 8:30 PM. The study focuses on outcomes within 14 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 14 days after starting the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05069428

Delirium Reduction With Ramelteon

Recruiting
PHASE4Ages 18+InterventionalTreatment
Centennial Medical Center
~506 participants
Updated 2024-08-22 on ClinicalTrials.gov
What's tested:Ramelteon 8mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Days alive without delirium or coma in the ICU
Measured over 14 days

Conditions

Delirium

Explore related trials

Delirium

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Jennifer Johnson, MD · PRINCIPAL_INVESTIGATOR · Centennial Medical Center

Who to contact

Jennifer Johnson, MD
[email protected]
214 604-8665
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Days alive without delirium or coma in the ICU14 days

    joint modeling approach taking account recurrence and terminating events