NCT06509191 The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
| NCT ID | NCT06509191 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sultan Qaboos University |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2024-09-30 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06509191 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06509191 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06509191 currently recruiting?
Yes, NCT06509191 is actively recruiting participants. Contact the research team at dr.abdullahalalawi@gmail.com for enrollment information.
Where is the NCT06509191 trial being conducted?
This trial is being conducted at Muscat, Oman, Muscat, Oman.
Who is sponsoring the NCT06509191 clinical trial?
NCT06509191 is sponsored by Sultan Qaboos University. The trial plans to enroll 240 participants.