The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Delirium
In brief
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 facts
- Study ID
- NCT06509191
- Run by
- Sultan Qaboos University
- People needed
- 240
- Starts
- 2024-09-30
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-01-14
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
You may not qualify if…
- 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 is running
- Sultan Qaboos University Hospital — Muscat, Oman (enrolling)
- Sultan Qaboos University Hospital — Muscat, Oman
Full record on ClinicalTrials.gov
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