Delirium Reduction With Ramelteon

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Centennial Medical Center
Study ID
NCT05069428
Phase
PHASE4
Status
Recruiting
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Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramelteon 8mg — DRUG
    administered crushed, orally at 20:30

Study Details

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 Dates

Start date
Mar 26, 2023
Status verified
Aug 2024
Primary completion
Mar 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
506 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ramelteon
    ramelteon 8 mg crushed tablet daily at 20:30
  • Placebo Comparator: placebo
    placebo powder equivalent grams at 20:30

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Centennial Medical CenterNashvilleTennessee37205
Jennifer Johnson, MD
[email protected]
214-604-8665
Chelsea Mitchell, ParmD
[email protected]
6153424725

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By research site
Centennial Medical Center· Nashville, TN

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