Results from a double blinded, randomised, placebo-controlled, feasibility trial of melatonin for the treatment of delirium in older medical inpatients.
Study Goal
To determine the feasibility of a trial using oral melatonin 5 mg nightly for five nights to treat delirium in older medical inpatients and assess the required sample size for a statistically significant reduction in delirium severity.
Results Summary
Melatonin showed no adverse effects, but the mean change in delirium severity (MDAS) was not significantly different between the melatonin and placebo groups. A larger trial with 120 participants is suggested to detect a clinically meaningful effect.
Population
Older inpatients (≥70 years) with hyperactive or mixed delirium in a general internal medicine unit.
Effective Dosage
5 mg nightly
Duration
Five nights
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
oral melatonin 5 mg nightly for five nights | no change | Memorial Delirium Assessment Scale (MDAS) | older (≥70 years) inpatients with confusion assessment method positive hyperactive or mixed delirium | 2.5 ± 5.0 points vs 2.1 ± 4.1 points | non-significant difference | #1 |
melatonin 5 mg | decrease | severity of delirium | older medical inpatients | by 3 points or more on MDAS | reduces the severity of delirium | #2 |
oral melatonin 5 mg nightly for five nights | no change | adverse effects | - | - | no adverse effects occurred | #3 |
BACKGROUND: Delirium is common in elderly inpatients, causing distress, cognitive decline and death. No known intervention improves the course of delirium; current treatments are symptomatic, and limited by lack of efficacy and adverse effects. There is an urgent need to find an effective treatment for delirium. AIMS: To determine the feasibility of a trial of oral melatonin 5 mg nightly for five nights for the treatment of delirium in older medical inpatients, and determine the participants required to demonstrate a clinically and statistically significant decrease in severity of delirium in older medical inpatients treated with melatonin. METHODS: This was a double blinded, randomised controlled trial in general internal medicine units of a tertiary teaching hospital. Older (≥70 years) inpatients with confusion assessment method positive hyperactive or mixed delirium were suitable for inclusion. Subjects received melatonin 5 mg oral nightly for five nights or matching placebo. The primary outcome was the Memorial Delirium Assessment Scale (MDAS) administered daily. RESULTS: No adverse effects occurred due to melatonin. In the treatment group, the mean change in MDAS from baseline during treatment period was 2.5 ± 5.0 points, in the placebo group, 2.1 ± 4.1 points, a non-significant difference. A power calculation accounting for drop-out (31.0%), suggests 120 participants would be required to demonstrate with 90% power that melatonin 5 mg reduces the severity of delirium by 3 points or more on MDAS. CONCLUSIONS: A trial of the hypothesis that 5 mg melatonin nightly for five nights reduces delirium severity in older medical inpatients would require 120 patients, and is feasible.