Study Summary
This trial will study the use of melatonin to treat delirium in critically ill adults. Results will help determine if a larger study is needed.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 8 months
14 days
Clinical: Adverse events
Clinical: Antipsychotics dose (mg) administered to participants
Clinical: Duration of delirium
8 months
Feasibility: Completion of ICDSC
Feasibility: Completion of study
Feasibility: Consent rate
Feasibility: Enrollment rate
Feasibility: MDAS assessment time (minutes)
Feasibility: Study adherence
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Melatonin
42%Fatigue
39%Early Morning Wakening
36%Daytime drowsiness
11%Dizziness
11%Blurred vision
11%Weakness
11%Nausea
Trial Design
2 Treatment Groups
Enteral melatonin 9 mg
1 of 2
Enteral placebo
1 of 2
Experimental Treatment
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: Enteral melatonin 9 mg · Has Placebo Group · Phase 2
Enteral melatonin 9 mg
Drug
Experimental Group · 1 Intervention: Melatonin · Intervention Types: DrugEnteral placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
58 Previous Clinical Trials
3,971 Total Patients Enrolled
1 Trials studying Delirium
23 Patients Enrolled for Delirium
Maisonneuve-Rosemont HospitalOTHER
97 Previous Clinical Trials
36,424 Total Patients Enrolled
2 Trials studying Delirium
1,314 Patients Enrolled for Delirium
François Marquis, M.D., M.A.Principal InvestigatorCentre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est-de-l'Île-de-Montréal
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Flacker JM, Lipsitz LA. Neural mechanisms of delirium: current hypotheses and evolving concepts. J Gerontol A Biol Sci Med Sci. 1999 Jun;54(6):B239-46. doi: 10.1093/gerona/54.6.b239. Erratum In: J Gerontol A Biol Sci Med Sci 1999 Jul;54(7):B275.
- Pandharipande PP, Morandi A, Adams JR, Girard TD, Thompson JL, Shintani AK, Ely EW. Plasma tryptophan and tyrosine levels are independent risk factors for delirium in critically ill patients. Intensive Care Med. 2009 Nov;35(11):1886-92. doi: 10.1007/s00134-009-1573-6. Epub 2009 Jul 9.
- Stollings JL, Kotfis K, Chanques G, Pun BT, Pandharipande PP, Ely EW. Delirium in critical illness: clinical manifestations, outcomes, and management. Intensive Care Med. 2021 Oct;47(10):1089-1103. doi: 10.1007/s00134-021-06503-1. Epub 2021 Aug 16.
- Sun T, Sun Y, Huang X, Liu J, Yang J, Zhang K, Kong G, Han F, Hao D, Wang X. Sleep and circadian rhythm disturbances in intensive care unit (ICU)-acquired delirium: a case-control study. J Int Med Res. 2021 Mar;49(3):300060521990502. doi: 10.1177/0300060521990502.
- Weinhouse GL, Schwab RJ, Watson PL, Patil N, Vaccaro B, Pandharipande P, Ely EW. Bench-to-bedside review: delirium in ICU patients - importance of sleep deprivation. Crit Care. 2009;13(6):234. doi: 10.1186/cc8131. Epub 2009 Dec 7.
- Farasat S, Dorsch JJ, Pearce AK, Moore AA, Martin JL, Malhotra A, Kamdar BB. Sleep and Delirium in Older Adults. Curr Sleep Med Rep. 2020;6(3):136-148. doi: 10.1007/s40675-020-00174-y. Epub 2020 Jul 27.
- Burry 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.
- Thabane, Lehana, Jinhui Ma, Rong Chu, Ji Cheng, Afisi Ismaila, Lorena P Rios, Reid Robson, Marroon Thabane, Lora Giangregorio, and Charles H Goldsmith. 2010. “A Tutorial on Pilot Studies: The What, Why and How”. BMC Medical Research Methodology. Springer Science and Business Media LLC. doi:10.1186/1471-2288-10-1.
- 2023. "Melatonin for Treatment of Delirium in Critically Ill Adult Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05713877.
Frequently Asked Questions
How hazardous could the ingestion of Enteral melatonin 9 mg be to individuals?
"Our experts at Power rated the safety of Enteral melatonin 9 mg as a 2 due to there being some evidence that it is secure, but no proof of its efficacy." - Anonymous Online Contributor
Unverified Answer
Are there any available openings for participants in this clinical trial?
"Data from clinicaltrials.gov implies that this particular medical trial is not currently garnering participants, despite being posted on the 1st of February 2021 and edited 6 days later. Although recruitment has ceased in this study, 145 other trials are actively accepting volunteers at present." - Anonymous Online Contributor
Unverified Answer