Delirium Reduction With Ramelteon

NCT05069428 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2021-438
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Days alive without delirium or coma in the ICU

  joint modeling approach taking account recurrence and terminating events

  14 days

Secondary Outcomes (5)

• Mean daily Confusion Assessment Method -7 CAM-ICU-7 score

  14 days

• Incidence of delirium, as defined by a positive CAM-ICU-7

  14 days

• Mortality at 14 days from randomization or hospital discharge

  14 days

• Duration of delirium, defined as number of days CAM-ICU positive

  14 days

• ICU length of stay

  14 days

Study Arms (2)

ramelteon

EXPERIMENTAL

ramelteon 8 mg crushed tablet daily at 20:30

Drug: Ramelteon 8mg

placebo

PLACEBO COMPARATOR

placebo powder equivalent grams at 20:30

Drug: Ramelteon 8mg

Interventions

Ramelteon 8mg DRUG

administered crushed, orally at 20:30

placebo; ramelteon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Centennial Medical Center: lead

Study Sites (1)

Centennial Medical Center

Nashville, Tennessee, 37205, United States

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jennifer Johnson, MD

  Centennial Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Johnson, MD

CONTACT

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

Chelsea Mitchell, PharmD

CONTACT

615 342-4725; chelsea.mitchell@hcahealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized, double-blinded, placebo controlled

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: March 26, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)