Recruiting
Phase 2

Melatonin

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT02615340

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Melatonin

Placebo

Study Details

Brief summary:

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for prevention of delirium in critically ill adult patients. The investigators hypothesize that melatonin, administered on a scheduled nightly basis during ICU admission, will be efficacious and safe for the prevention of delirium in critically ill adults.

Conditions

Delirium

Study ID

NCT02615340

Start date

Oct 12, 2017

Status verified date

Oct, 2017

Completion date

Oct 12, 2019

Anticipated

Primary completion date

Oct 12, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Critically ill patients ≥18 years of age
2. Anticipated ICU stay of >48 hours
3. Able to receive enteral administration of study drug (i.e. by mouth or any feeding tube = naso- or oro- or percutaneous gastric or post-pyloric feeding tube)
4. Consent to participate.

Exclusion Criteria:

1. ICU admission of >48 hours prior to screening
2. Unable to assess for delirium (e.g. comatose defined as SAS 1 or 2 or either 'No Response' Score A or B on ICDSC, chemically paralyzed with neuromuscular blocking drugs)
3. Screened delirium positive prior to randomization (ICDSC score ≥4 out of 8)
4. Anticipated withdrawal in next 48 hours
5. Known history of severe cognitive or neurodegenerative disease (e.g. dementia, Parkinson's disease) or severe structural brain injury (e.g. traumatic brain injury, intracranial hemorrhage) as the ICDSC assessment tool has not been validated in these patient populations
6. Unable to communicate in English or French (Montreal site)
7. Contraindications to receiving any enteral medication (defined as absolute contraindication to enteral nutrition such as gastrointestinal obstruction, perforation, recent upper GI surgery, no enteral access)
8. Active seizures
9. Known pregnancy
10. Legal blindness
11. Known allergy to melatonin

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Enteral melatonin 0.5 mg

Melatonin 0.5 mg from the 1mg/mL oral suspension qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration of 0.1 mg/mL; final volume in the oral syringe will be 5 mL)

active comparator: Enteral melatonin 2 mg

Melatonin 2 mg from the 1mg/mL oral suspension qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration 0.4 mg/mL; final volume in the oral syringe will be 5 mL)

placebo comparator: Enteral matched placebo

Melatonin 0 mg qs to 5 mL with Oral Mix SF (sugar-free flavoured suspending vehicle) (final concentration 0 mg/mL; final volume in the oral syringe will be 5 mL)

Interventions

Melatonin

Study drug will be given at 21:00 - 23:59 daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days, as most critically ill patients are at greatest risk of delirium in the first two weeks of admission. The study medication will be given by mouth (PO or per os) or if needed, via the feeding tube followed by a flush with 20mL water. Doses can be given up to midnight if administration needs to be delayed for procedures or investigations.

Placebo

Study drug will be given at 21:00 - 23:59 daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days, as most critically ill patients are at greatest risk of delirium in the first two weeks of admission. The study medication will be given by mouth (PO or per os) or if needed, via the feeding tube followed by a flush with 20mL water. Doses can be given up to midnight if administration needs to be delayed for procedures or investigations.

Primary outcome measure

  • Feasibility: Study adherence [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Lisa Burry, PharmD

4165864800lisa.burry@sinaihealthsystem.ca

Louise Rose

416978-3492louise.rose@utoronto.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Lisa Burry, PharmD

lisa.burry@sinaihealthsystem.ca

Principal Investigator:

Lisa Burry

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Damon Scales

damon.scales@sunnybrook.ca

Principal Investigator:

Damon Scales, MD PhD

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Oct 19, 2017

Last verified

Oct, 2017

Keywords

  • delirium
  • melatonin
  • pharmacokinetics
  • feasibility
  • prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2017-10-19.