Melatonin for Delirium Reduction, Resolution And Mitigation of Abnormal Arousal (MelaDRRAMAA)

Melatonin for Delirium Reduction, Resolution And Mitigation of Abnormal Arousal (MelaDRRAMAA): a double blinded placebo-controlled randomised trial of Melatonin 5mg nightly for 5 nights for the reduction of severity of delirium in older adult medical inpatients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000034134

Acronym

MelaDRRAMAA

Enrollment

120

Registered

2019-01-11

Start date

2021-03-11

Completion date

2022-03-07

Last updated

2022-04-25

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

Conditions

None listed

Brief summary

Delirium is the sudden onset of confusion or hallucinations, due to an illness or medication. It affects the elderly particularly, and is both distressing to the sufferer and their carers, as well as causing death, disability and institutionalisation. Melatonin is a naturally occurring hormone in the human brain important in sleep. Sleep is disturbed in delirium, and studies have shown melatonin can prevent delirium. This study aims to determine whether Melatonin 5mg in oral capsules given nightly for 5 nights can treat and cure delirium that has developed in older patients in hospital.

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

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of delirium (regardless of cause) Inpatient of the Royal Melbourne Hospital

Exclusion criteria

- exclusively hypoactive delirium, - recent stroke (<14 days), - sensory impairment or dysphasia or language such that not evaluable, - planned for surgery, - prognosis <7days, - severe hepatic failure - allergy or intolerance to melatonin or excipients. - Treated with Melatonin or melatonin agonists within 24 hours prior to enrolment

Outcome results