DeliriumPhase 2MELLOW-1NCT02615340
Melatonin for Prevention of Delirium in Critically Ill Patients
A Phase 2 study testing Melatonin in people with Delirium, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Oct 2017to 12 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients ≥18 years of age
- Anticipated ICU stay of >48 hours
- 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)
- Consent to participate.
Who cannot join
- ICU admission of >48 hours prior to screening
- 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)
- Screened delirium positive prior to randomization (ICDSC score ≥4 out of 8)
- Anticipated withdrawal in next 48 hours
- 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
- Unable to communicate in English or French (Montreal site)
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- 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)
- Active seizures
- Known pregnancy
- Legal blindness
- Known allergy to melatonin
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Not yet recruiting
Hôpital du Sacré-Coeur
Montreal, Quebec
David Williamson, david.williamson@umontreal.ca
David Williamson, PhD
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Lisa Burry, PharmD, lisa.burry@sinaihealthsystem.ca
Lisa Burry
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Damon Scales, damon.scales@sunnybrook.ca
Damon Scales, MD PhD
About this study
Official title: Feasibility of Melatonin for Prevention of Delirium in Critically Ill Patients: a Multi-centre, Randomized, Placebo-controlled Study.
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.
Read the detailed description
The available evidence indicates melatonin may decrease the incidence of delirium in non-critically ill patient populations; however, trials in the critically ill are lacking. 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. The null hypothesis is that there is no difference in delirium incidence between placebo and melatonin. Prior to conducting an adequately powered multi-centre, blinded randomized, placebo-controlled trial in critically ill patients, there is a need for a better understanding of melatonin pharmacokinetics (PK) in critically ill patients. This will help to determine appropriate dosing, drug administration issues (specifically protocol adherence), adverse drug effects, and recruitment rates based on inclusion and exclusion criteria.
The specific aim is to conduct a phase II triple blind, placebo-controlled randomized trial comparing two doses of melatonin (low dose = 0.5 mg and high dose = 2.0 mg) to assess the feasibility of a future full-scale RCT. Feasibility of the larger trial will be based on protocol adherence and participant recruitment rates. Data on PK properties of melatonin will be assessed to determine dosing for future studies of melatonin for delirium prevention in the critically ill.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called N-acetyl-5-methoxytryptamine
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Enteral melatonin 0.5 mg | Active comparator | 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) Receives: Drug: Melatonin |
| Enteral melatonin 2 mg | Active comparator | 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) Receives: Drug: Melatonin |
| Enteral matched placebo | Placebo comparator | 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Study adherence
Investigators will calculate protocol adherence as the overall proportion of administered doses in the prescribed dose administration window (between 21:00 and to 23:59 hours) divided by total number of eligible study days.
Measured: 1 year
Secondary outcomes (18)
Feasibility: Trial recruitment
Proportion of ICU patients screened that meet study inclusion criteria, the number of patients excluded and reasons for exclusion, and the consent rate of eligible participants.
Measured: 1 year
Feasibility: Time in motion (minutes)
Research coordinators at each site will capture the amount of time (minutes) taken to screen, consent, and enrol patients, complete study procedures, and collect data.
Measured: 1 year
Pharmacokinetic: Peak melatonin concentration (Cmax)
Peak melatonin concentration. Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Pharmacokinetic: Time of peak melatonin concentration (Tmax)
Time of peak melatonin concentration (Tmax). Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Pharmacokinetic: Morning melatonin concentration (C9AM)
Morning melatonin concentration (C9AM). Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Pharmacokinetic: Melatonin half-life (T½)
Melatonin half-life (T½). Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Pharmacokinetic: Mean apparent clearance (CL/F)
Mean apparent clearance (CL/F). Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Pharmacokinetic: Mean apparent volume distribution (V/F)
Mean apparent volume distribution (V/F). Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Pharmacokinetic: Area under the concentration-time curve (AUC)
Area under the concentration-time curve (AUC). Plasma melatonin concentrations measured by mass spectrometry. N=5 from each study arm of Mount Sinai Hospital site.
On study day 1, eight blood samples (4 mL each) will be collected at the following intervals, from the time of first study drug dose to the following morning (time 0, 0.5, 1, 2, 4, 6, 8, 12 hours).
Measured: 24 hours
Clinical: Adverse events
Adverse events reported by the participant, family, or treating team. The following potential adverse effects will be collected: morning drowsiness (Sedation Agitation Scale (SAS) score <3 or patient's self report of drowsiness between 07:00h and 12:00h), headache, and vivid dreams.
Measured: 14 days
Clinical: Delirium incidence
Intensive Care Delirium Screening Checklist (ICDSC) administered daily. Delirium defined as an ICDSC score ≥4.
Measured: 14 days
Clinical: Delirium time to onset and duration (days)
Time to onset of first ICDSC score ≥4, and number of days with ICDSC score ≥4.
Measured: 14 days
Clinical: Sleep
Richards Campbell Sleep Questionnaire (RCSQ) administered daily, where possible. Patients with or without the assistance of their nurse will be asked to complete the questions of the RCSQ each morning. Nurses will not complete the RCSQ if the patient is unable to verbalize, as poor correlation has been shown between patient and nursing scores.
Measured: 14 days
Clinical: Duration of mechanical ventilation
Duration of mechanical ventilation (days)
Measured: ICU admission
Clinical: ICU length of stay
Duration of stay for index ICU admission (days)
Measured: ICU admission
Clinical: Hospital length of stay
Duration of stay for admission involving trial enrolment (days)
Measured: 1 year
Clinical: ICU mortality
Number of deaths during index ICU admission
Measured: 1 year
Clinical: Hospital mortality
Number of deaths during hospital admission
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start12 Oct 2017
- Primary completion12 Oct 2018 (estimated)
- Study completion12 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Responsible party
- Sponsor
- Investigators
- Lisa Burry, PharmD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615340
- Sponsor's protocol ID
- 4000145150
- Acronym
- MELLOW-1
- Status last verified
- Oct 2017
- First submitted
- 19 Nov 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burry LD, Williamson DR, Detsky ME, Bernard F, Foster J, Mehta S, Pinto R, Scales DC, Rose L. Low-Dose Melatonin for Prevention of Delirium in Critically Ill Patients: A Multicenter, Randomized, Placebo-Controlled Feasibility Trial. Chest. 2025 May;167(5):1397-1407. doi: 10.1016/j.chest.2024.12.030. Epub 2025 Jan 10.
PubMed 39800236Burry L, Scales D, Williamson D, Foster J, Mehta S, Guenette M, Fan E, Detsky M, Azad A, Bernard F, Rose L. Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study. BMJ Open. 2017 Mar 30;7(3):e015420. doi: 10.1136/bmjopen-2016-015420.
PubMed 28363933
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Melatonin for Prevention of Delirium in Critically Ill Patients: a Multi-centre, Randomized, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT02615340
- Acronym / sponsor ID
- MELLOW-1 / 4000145150
- Conditions
- Delirium
- Keywords
- delirium, melatonin, pharmacokinetics, feasibility, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 12 Oct 2018 (estimated)
- Study completion
- 12 Oct 2019 (estimated)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The available evidence indicates melatonin may decrease the incidence of delirium in non-critically ill patient populations; however, trials in the critically ill are lacking. 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. The null hypothesis is that there is no difference in delirium incidence between placebo and melatonin. Prior to conducting an adequately powered multi-centre, blinded randomized, placebo-controlled trial in critically ill patients, there is a need for a better understanding of melatonin pharmacokinetics (PK) in critically ill patients. This will help to determine appropriate dosing, drug administration issues (specifically protocol adherence), adverse drug effects, and recruitment rates based on inclusion and exclusion criteria.
The specific aim is to conduct a phase II triple blind, placebo-controlled randomized trial comparing two doses of melatonin (low dose = 0.5 mg and high dose = 2.0 mg) to assess the feasibility of a future full-scale RCT. Feasibility of the larger trial will be based on protocol adherence and participant recruitment rates. Data on PK properties of melatonin will be assessed to determine dosing for future studies of melatonin for delirium prevention in the critically ill.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enteral melatonin 0.5 mg | Active comparator | Drug: MelatoninMelatonin 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) |
| Enteral melatonin 2 mg | Active comparator | Drug: MelatoninMelatonin 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) |
| Enteral matched placebo | Placebo comparator | Drug: PlaceboMelatonin 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critically ill patients ≥18 years of age
- Anticipated ICU stay of >48 hours
- 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)
- Consent to participate.
Key exclusion criteria (11 listed)
- ICU admission of >48 hours prior to screening
- 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)
- Screened delirium positive prior to randomization (ICDSC score ≥4 out of 8)
- Anticipated withdrawal in next 48 hours
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: N-acetyl-5-methoxytryptamineStudy 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. | Drug | Enteral melatonin 0.5 mg, Enteral melatonin 2 mg |
| PlaceboStudy 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. | Drug | Enteral matched placebo |
Primary outcome
Feasibility: Study adherence
Time frame: 1 year
Investigators will calculate protocol adherence as the overall proportion of administered doses in the prescribed dose administration window (between 21:00 and to 23:59 hours) divided by total number of eligible study days.
18 secondary outcomes
Feasibility: Trial recruitment
Time frame: 1 year
Feasibility: Time in motion (minutes)
Time frame: 1 year
Pharmacokinetic: Peak melatonin concentration (Cmax)
Time frame: 24 hours
Pharmacokinetic: Time of peak melatonin concentration (Tmax)
Time frame: 24 hours
Pharmacokinetic: Morning melatonin concentration (C9AM)
Time frame: 24 hours
Pharmacokinetic: Melatonin half-life (T½)
Time frame: 24 hours
Pharmacokinetic: Mean apparent clearance (CL/F)
Time frame: 24 hours
Pharmacokinetic: Mean apparent volume distribution (V/F)
Time frame: 24 hours
Pharmacokinetic: Area under the concentration-time curve (AUC)
Time frame: 24 hours
Clinical: Adverse events
Time frame: 14 days
Clinical: Delirium incidence
Time frame: 14 days
Clinical: Delirium time to onset and duration (days)
Time frame: 14 days
Clinical: Sleep
Time frame: 14 days
Clinical: Duration of mechanical ventilation
Time frame: ICU admission
Clinical: ICU length of stay
Time frame: ICU admission
Clinical: Hospital length of stay
Time frame: 1 year
Clinical: ICU mortality
Time frame: 1 year
Clinical: Hospital mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Derived from this study: PubMed 39800236Burry LD, Williamson DR, Detsky ME, Bernard F, Foster J, Mehta S, Pinto R, Scales DC, Rose L. Low-Dose Melatonin for Prevention of Delirium in Critically Ill Patients: A Multicenter, Randomized, Placebo-Controlled Feasibility Trial. Chest. 2025 May;167(5):1397-1407. doi: 10.1016/j.chest.2024.12.030. Epub 2025 Jan 10.
- Derived from this study: PubMed 28363933Burry L, Scales D, Williamson D, Foster J, Mehta S, Guenette M, Fan E, Detsky M, Azad A, Bernard F, Rose L. Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study. BMJ Open. 2017 Mar 30;7(3):e015420. doi: 10.1136/bmjopen-2016-015420.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Burry, PharmD principal investigator
MOUNT SINAI HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Delirium, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Burry, PharmD (4165864800 ext. 4820, lisa.burry@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Study adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.