Melatonin vs. placebo for the symptoms of delirium in elderly medical inpatients

A double blinded, randomised, placebo controlled pilot trial of moderate dose melatonin for the abatement and treatment of delirium in elderly general medical inpatients.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000101684

Acronym

MFDAT

Enrollment

Registered

2014-01-28

Start date

2014-05-19

Completion date

2016-07-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a pilot trial testing the feasibility and participants required to test the hypothesis that melatonin 5mg capsule every night will decrease the symptoms of delirium in elderly medical inpatients.

Interventions

Melatonin 5mg oral capsule nightly for 5 days administered directly by hospital nursing staff.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of delirium (regardless of cause) Inpatient under general medicine of the The Royal Melbourne Hospital

Exclusion criteria

Exclusively hypoactive delirium, recent stroke (<14 days), sensory impairment or dysphasia or language such that not evaluable, undergoing surgery, prognosis <7days, severe hepatic or renal failure, allergy or intolerance to melatonin or excipients.

Outcome results