The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients

Sponsor
Sultan Qaboos University
Study ID
NCT06509191
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Delirium

Eligibility Criteria

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

Interventions

  • Intervention 1 — DRUG
    Melatonin 5mg/day
  • Intervention 2 — DRUG
    Melatonin 8 mg/day
  • Control — OTHER
    Placebo

Study Details

The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored melatonin's potential in preventing delirium among patients admitted to general medical wards. Previous trials on melatonin's preventive role in medical wards had limitations, necessitating a robust, double-blinded, placebo-controlled design with a larger sample size. This randomized, double-blind study of melatonin versus placebo aims to investigate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 or older. Given the high prevalence of delirium in this population and its association with adverse outcomes, the study seeks to contribute valuable insights into an effective preventive strategy.

Key Dates

First listed
Jul 19, 2024
Start date
Sep 30, 2024
Status verified
Jan 2025
Primary completion
Mar 31, 2025
Completion
Jun 30, 2025

Study Design

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

Arms

  • Experimental: Melatonin 5mg/day
    Intervention group 1: Melatonin 5mg/day * Study drug will be given at 20:00 - 22:00 daily, starting on the day of enrolment until discharge, death, or up to 5 days as most medically hospitalised patients at great risk of delirium in the first few days of admission.(20) * The study medication will be given by mouth or if needed, via the feeding tube followed by a flush with 20mL water.
  • Experimental: Melatonin 8 mg/day
    Intervention group 2:Study drug will be given at 20:00 - 22:00 daily, starting on the day of enrolment until discharge, death, or up to 5 days as most medically hospitalised patients at great risk of delirium in the first few days of admission.(20) • The study medication will be given by mouth or if needed, via the feeding tube followed by a flush with 20mL water.
  • Placebo Comparator: Placebo
    * Study drug will be given at 20:00 - 22:00 daily, starting on the day of enrolment until discharge, death, or up to 5 days as most medically hospitalised patients at great risk of delirium in the first few days of admission. (20) * The study medication will be given by mouth or if needed, via the feeding tube followed by a flush with 20mL water.

Primary Outcome Measure

Incidence of delirium [ Time Frame: 5 days ]

Central Contacts

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