Sha 2019 / Minted

Study ID(s) and Acronym(s)
Minted
Current Status of Trial
Completed
Study Aim
Other
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Melatonin // Placebo
Dosage and Duration
Participants were randomised to receive slow-release melatonin 4mg or placebo daily for five days.
Absolute Number of Participants
10
Health Status/Diagnosis
Hospitalised patients
Primary outcomes
Delirium severity
Key Points
"Ten (melatonin n = 5, placebo n = 5) patients were included in the study. MDAS score on day 5 was similar between the two groups (10.3 +/- 8.3 vs 8.5 +/- 1.9 P = 0.6). The melatonin group had a longer total sleep time (292 +/- 41mins vs 211+/-80mins P = 0.075) and shorter sleep latency (113 +/- 46 mins vs 151 +/- 32mins P = 0.17), but the difference did not reach statistical significance. Conclusion(s): This trial confirmed the feasibility of conducting a randomised controlled study in an elderly delirious population. Although no statistically significant impact on delirium severity was demonstrated, the trend seen in improved sleep architecture in the melatonin group warrants further exploration in a larger study." Sha 2019