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Prevention study for Delirium
Official title The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
ClinicalTrials.gov ID: NCT06509191
What this study is testing
What is Intervention 1?
Intervention 1 is an investigational medicine, being studied as a potential treatment for delirium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
You likely can't join 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.
See the full eligibility criteria
- Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Muscat, Oman
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Muscat, Oman. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.