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Melatonin Use in the Intensive Care Elderly Population (MICE Trial)

Phase 4
Waitlist Available
Research Sponsored by MICE Trial Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Non-ventilated Patients over the age of 65
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

The investigators are studying the use of Melatonin in non-ventilated patients over the age of 65. Primary endpoint will be assesments of delirium, with secondary endpoints to include length of stay, use of anti-psychotic medications, and mortality

Eligible Conditions
  • Delirium
  • Melatonin

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Melatonin 5mgActive Control1 Intervention
This arm will be given 5mg tablets of Melatonin nightly for the duration of their hospital stay
Group II: Melatonin 3mgActive Control1 Intervention
This arm will be given 3mg tablets of Melatonin nightly for the duration of their hospital stay
Group III: PlaceboPlacebo Group1 Intervention
This arm will be given a Sucrose tablet nightly for the duration of their hospital stay

Find a Location

Who is running the clinical trial?

MICE Trial GroupLead Sponsor
~67 spots leftby Dec 2025
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