Delirium Reduction With Ramelteon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-26

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Melatonin is an endogenous hormone that regulates the sleep-wake cycle along with several other physiological functions. It is reported that melatonin secretion may be impaired in ICU patients, and there is some question whether this may be a contributing factor to delirium occurrence. Ramelteon is a melatonin agonist with three to six times increased affinity for MT1 and MT2 receptors versus melatonin. It is FDA approved for the treatment of insomnia, and some studies suggested some benefit with ramelteon for delirium prevention. There is limited prospective research data assessing the efficacy of ramelteon for delirium treatment. The goal of this study therefore is to assess the efficacy of ramelteon versus placebo on the prevention and treatment of delirium in ICU patients.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blinded, placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ramelteon

ramelteon 8 mg crushed tablet daily at 20:30

Group Type EXPERIMENTAL

Ramelteon 8mg

Intervention Type DRUG

administered crushed, orally at 20:30

placebo

placebo powder equivalent grams at 20:30

Group Type PLACEBO_COMPARATOR

Ramelteon 8mg

Intervention Type DRUG

administered crushed, orally at 20:30

Interventions

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Ramelteon 8mg

administered crushed, orally at 20:30

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No