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Melatonin to treat Delirium in Older People

Melatonin to reduce sedative use in older general medical inpatients with delirium

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001537347
Enrollment
6
Registered
2017-11-06
Start date
2017-11-28
Completion date
2018-01-31
Last updated
2018-06-11

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 an acute confusional state that is a medical emergency and is associated with significant morbidity and mortality. Delirium can often disrupt the times when someone is sleeping or awake. Although the main management of delirium is based on treatment of the underlying causes, specific medications are sometimes necessary to manage delirium-related behaviours. These interventions include the use of sedating medications that are associated with an increased risk of substantial harm. Melatonin is a natural-occurring substance made in the brain that helps regulate the timing of sleep and wakefulness. It is a well-established treatment for insomnia, has a good safety profile and has a potential theoretical benefit in the management of delirium by correcting the sleep-wake cycle disruption commonly seen in delirium. Although it has been used to manage delirium in hospitals around the world for some years, there have been no scientific trials to examine its effectiveness. Melatonin is approved in Australia to treat insomnia. However it is not approved to manage delirium. Therefore, it is an experimental treatment for delirium. This means that it must be tested to see if it is an effective treatment for delirium. This study aims to examine the effect of melatonin on delirium.

Interventions

Melatonin 2mg oral capsule nightly for 7 nights administered by hospital nursing staff.

Sponsors

Alfred Health
Lead SponsorHospital

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
No

Inclusion criteria

Diagnosis of delirium (regardless of cause) admitted to general medicine unit at Alfred Health

Exclusion criteria

Currently use of melatonin Current use of antipsychotic or benzodiazepine medication Allergy to melatonin Unable to swallow capsule

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026