Recruiting

Melatonin

Sponsor:

MICE Trial Group

Code:

NCT03013790

Conditions

Delirium

Melatonin

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Melatonin

Study Details

Brief 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

Conditions

Delirium

Melatonin

Study ID

NCT03013790

Start date

Dec, 2016

Status verified date

Jul, 2017

Completion date

Jan, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Non-ventilated Patients over the age of 65

Exclusion Criteria:

  • Patients with head trauma or Neurosurgical intervention
  • Patients <65 years of age
  • Patients with an expected life expectancy <48 hours
  • Blind patients
  • Patients with a seizure history
  • Patients with uncontrolled hypertension
  • Patients with a supratheraputic (>3.0) INR
  • Patients on strong CYP1A2 inhibitors: ciprofloxacin, fluvoxamine, methoxsalen, ofloxacin, primaquine
  • Patients who do not speak English or Spanish

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Melatonin 5mg

This arm will be given 5mg tablets of Melatonin nightly for the duration of their hospital stay

active comparator: Melatonin 3mg

This arm will be given 3mg tablets of Melatonin nightly for the duration of their hospital stay

placebo comparator: Placebo

This arm will be given a Sucrose tablet nightly for the duration of their hospital stay

Interventions

Melatonin

Patients will receive Melatonin at 2 different doses or a placebo

Primary outcome measure

  • Delirium [ Time Frame: Length of Hospital Stay, Average of 1 week ]

Central Contacts and Locations

Central contacts

Mike Forte, DO

7195641542mike_forte@parkviewmc.com

Josh Gordon, DO

7195641542joshiah_gordon@parkviewmc.com

Locations

Parkview Medical Center

Recruiting

Pueblo, Colorado, United States, 81003

Contacts

Mike Forte, DO

719-564-1542mike_forte@parkviewmc.com

Josh Gordon, DO

7195641542joshiah_gordon@parkviewmc.com

More Information

Sponsor

MICE Trial Group

Last update posted

Jul 13, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MICE Trial Group on 2017-07-13.