Trial reportBMJ open2026
Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE).
Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06509191 (Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients: Study Protocol for a Single-Center, Double-Blinded, Randomised Controlled Trial
Who cites it
1 citing paper in PubMed.
- Melatonin beyond chronobiology: integrating pharmacokinetics, dose-exposure forecasting, and clinical evidence.Molecular biology reports · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.
designSingle-centre, double-blinded, randomised, placebo-controlled trial.
settingGeneral medical wards of a tertiary hospital in Oman.
participantsPatients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.
interventionsParticipants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.
resultsThe study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.
conclusionsIn this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study's power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made. TRIAL REGISTRATION NUMBER: NCT06509191.
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