Recruiting

Ramelteon

Sponsor:

Centennial Medical Center

Code:

NCT05069428

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ramelteon 8mg

Study Details

Brief 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

Study ID

NCT05069428

Start date

Mar 26, 2023

Status verified date

Aug, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

506 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ramelteon

ramelteon 8 mg crushed tablet daily at 20:30

placebo comparator: placebo

placebo powder equivalent grams at 20:30

Interventions

Ramelteon 8mg

administered crushed, orally at 20:30

Primary outcome measure

  • Days alive without delirium or coma in the ICU [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Jennifer Johnson, MD

214 604-8665jennifer.johnson19@hcahealthcare.com

Chelsea Mitchell, PharmD

615 342-4725chelsea.mitchell@hcahealthcare.com

Locations

Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Jennifer Johnson, MD

214-604-8665jennifer.johnson19@hcahealthcare.com

Chelsea Mitchell, ParmD

6153424725chelsea.mitchell@hcahealthcare.com

More Information

Sponsor

Centennial Medical Center

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centennial Medical Center on 2024-08-22.