Moderate dose melatonin for the abatement and treatment of delirium in elderly general medical inpatients: study protocol of a placebo controlled, randomised, double blind trial.
Study Goal
The researchers aimed to determine if moderate-dose melatonin (5 mg) effectively treats delirium symptoms and modifies its natural history in elderly patients.
Results Summary
The study assessed melatonin's impact on delirium severity and duration using validated scales, but specific results were not detailed in the abstract. The discussion suggests melatonin is safe, cheap, and potentially effective, though efficacy data are pending.
Population
Elderly patients (≥70 years) admitted to the Royal Melbourne Hospital with delirium, excluding those requiring surgery.
Effective Dosage
5 mg melatonin nightly
Duration
5 nights (or until discharge)
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Prophylactic melatonin in low doses | decrease | delirium developing | - | - | has been shown to prevent | #1 |
melatonin at a moderate dose | decrease | the symptoms of delirium | - | - | effectively treats | #2 |
melatonin at a moderate dose | neutral | the natural history | - | - | modifies | #3 |
melatonin at a moderate dose | decrease | symptoms after treatment cessation | - | - | abating | #4 |
melatonin | decrease | the severity of delirium | Elderly (≥70 years of age) patients admitted to the Royal Melbourne Hospital with delirium | - | decreases | #5 |
melatonin | decrease | the duration of delirium | Elderly (≥70 years of age) patients admitted to the Royal Melbourne Hospital with delirium | - | decreases | #6 |
current pharmacological interventions | no change | hastening the resolution of delirium | elderly inpatients with delirium | - | show weak or no effect on | #7 |
BACKGROUND: Delirium is a frequent, costly and morbid problem. No agent has been shown to modify the natural history of the condition, and current treatments have significant side effects. Prophylactic melatonin in low doses has been shown to prevent delirium developing. This trial then aims to determine the feasibility of a trial to assess if melatonin at a moderate dose effectively treats the symptoms of delirium and modifies the natural history, including abating symptoms after treatment cessation. METHODS/DESIGN: Elderly (≥70 years of age) patients admitted to the Royal Melbourne Hospital with delirium, and not requiring surgery, will be identified from the current practice of the investigators and through referral by other general medical unit staff. To facilitate this, other staff will be briefed on the project by investigators. Patients will be recruited with suitable informed and documented consent (person responsible) by the study investigators. They will receive orally either 5 mg melatonin (18 patients) or placebo (18 patients) nightly for 5 nights (or until discharged). During treatment, participants will be assessed by study staff using a validated scale of delirium severity (the Memorial Delirium Assessment Scale), and a validated measure of delirium state (Confusion Assessment Method) to determine if melatonin decreases the severity or the duration of delirium. Assessment will continue for a further two days after treatment has ceased, to determine if the treatment causes persisting abatement of symptoms, and to assess for adverse events. DISCUSSION: The on-going study described herein will contribute to our knowledge of available treatment options for elderly inpatients with delirium, where current pharmacological interventions show weak or no effect on hastening the resolution of delirium. As melatonin is safe, cheap, and potentially effective, it would be easily implementable in routine practice and could lead to significant outcome benefits for delirious inpatients. TRIAL REGISTRATION: The trial is registered with the Australia New Zealand Clinical Trials Registry (trial ID: ACTRN12614000101684 ) (registered 28/01/2014).