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

Phase 2

Active, not recruiting

• Conditions: Delirium; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000034134
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-11
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of Delirium - Memorial Delirium Assessment Scale (MDAS) - during treatment phase[Change from baseline to mean MDAS over days 1-5]