Using melatonin to prevent delirium in hospitalized older patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy of melatonin, a neurohormone that regulates the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 and older. It employs a randomized, double-blind, placebo-controlled design to ensure robust results. Given the high prevalence of delirium in this demographic and its association with adverse health outcomes, the study aims to provide valuable insights into effective prevention strategies. The trial addresses limitations of previous studies by utilizing a larger sample size and a more rigorous methodology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit

Exclusion Criteria:

* Patients admitted to the ward, however meeting requirement for vasopressors or non-invasive ventilation.
* Patient admitted through emergency to Intensive Care Unit (ICU) or High Dependency Unit (HDU).
* Aphasic patients.
* Patients with language barriers.
* Already taking melatonin or ramelteon at the time of randomization.
* Presence of delirium at the time of randomization.
* If enteral medications are contraindicated due to gastrointestinal conditions.
* If enteral medications are not allowed due to unavailability of nasogastric tube
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (liver function tests) \> 3 times the upper limit of normal.
* Patient on strong cytochrome P450 1A2 (CYP1A2) inhibitors (namely: fluvoxamine and viloxazine) .
* Patient with active alcohol drinking or admitted with alcohol withdrawal syndrome.
* Subject or proxy unable to provide informed consent within 24 hours of admission.
* Patients with the following autoimmune diseases (Rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythematosus).
* Allergy to melatonin.

Where it's running

• Sultan Qaboos University Hospital
  Muscat, Oman Recruiting
• Sultan Qaboos University Hospital
  Muscat, Oman Not yet recruiting

Study contacts

• Study coordinator: Abdullah M Al Alawi, FRACP
• Email: dr.abdullahalalawi@gmail.com
• Phone: +96895384990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.