ActivePhase 2Phase 3ACTRN12619000034134

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


Sponsor

Royal Melbourne Hospital

Enrollment

120 participants

Start Date

Mar 11, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Inclusion Criteria2

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

Exclusion Criteria8

  • 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

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Interventions

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

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


Locations(1)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

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ACTRN12619000034134


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