NCT02615340 (MELLOW-1) is a Phase 2 clinical trial of Melatonin in Delirium, sponsored by Mount Sinai Hospital, Canada.

Who is sponsoring NCT02615340?

NCT02615340 is sponsored by Mount Sinai Hospital, Canada.

What drugs are being tested in NCT02615340?

Interventions in NCT02615340: Melatonin, Placebo.

Is NCT02615340 still recruiting?

NCT02615340 is currently status unknown. Last updated 19 October 2017.

Last reviewed 2017-10-19 · How we verify

NCT02615340: MELLOW-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Melatonin for Prevention of Delirium in Critically Ill Patients

Status unknown Phase 2 Last updated 19 October 2017

What this trial tests

Phase 2 trial testing Melatonin in Delirium in 69 participants. Status unknown.

Timeline

12 October 2017

Primary endpoint
12 October 2018

12 October 2019

Quick facts

Lead sponsor	Mount Sinai Hospital, Canada
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	69
Start date	12 October 2017
Primary completion	12 October 2018
Estimated completion	12 October 2019
Sites	3 locations across Canada

Drugs / interventions tested

Melatonin (MELATONIN) — full drug profile →
Placebo

Conditions studied

Delirium — all drugs for Delirium →

Sponsor

Mount Sinai Hospital, Canada

Who can join

18 and older, any sex, with Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Interventions for preventing intensive care unit delirium in adults.
Herling SF, Greve IE, Vasilevskis EE, Egerod I, et al · · 2018 · cited 70× · PMID 30484283 · DOI 10.1002/14651858.cd009783.pub2
Melatonin for the promotion of sleep in adults in the intensive care unit.
Lewis SR, Pritchard MW, Schofield-Robinson OJ, Alderson P, et al · · 2018 · cited 40× · PMID 29746721 · DOI 10.1002/14651858.cd012455.pub2
Promoting Sleep to Improve Delirium in the ICU.
Kamdar BB, Martin JL, Needham DM, Ong MK. · · 2016 · cited 17× · PMID 27858818 · DOI 10.1097/ccm.0000000000001982
Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study.
Burry L, Scales D, Williamson D, Foster J, et al · · 2017 · cited 15× · PMID 28363933 · DOI 10.1136/bmjopen-2016-015420
Current controversies and future perspectives on treatment of intensive care unit delirium in adults.
Cascella M, Fiore M, Leone S, Carbone D, et al · · 2019 · cited 9× · PMID 31240172 · DOI 10.5492/wjccm.v8.i3.18
Melatonin for Insomnia in Medical Inpatients: A Narrative Review.
Salahub C, Wu PE, Burry LD, Soong C, et al · · 2022 · cited 7× · PMID 36615056 · DOI 10.3390/jcm12010256
Low-Dose Melatonin for Prevention of Delirium in Critically Ill Patients: A Multicenter, Randomized, Placebo-Controlled Feasibility Trial.
Burry LD, Williamson DR, Detsky ME, Bernard F, et al · · 2025 · cited 6× · PMID 39800236 · DOI 10.1016/j.chest.2024.12.030

Verify or expand the search:

Other trials of Melatonin

Trials testing the same drug.

NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting

Other recruiting trials for Delirium

Currently open trials in the same condition.

NCT07348471 — Fecal Microbiota Transplantation for the Treatment of ICU Delirium · NA · recruiting
NCT06969287 — Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery · Phase 3 · recruiting
NCT07369258 — Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit · NA · recruiting
NCT07488468 — Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures · recruiting
NCT07136207 — Development and Validation of Delirium Recognition Using Computer Vision in Neuro-critical Patients · recruiting

Other Mount Sinai Hospital, Canada trials

Trials by the same sponsor.

NCT07272460 — Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial · NA · recruiting
NCT07046572 — Methoxyflurane for IUD Insertion and Endometrial Biopsy · NA · recruiting
NCT06504277 — Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain · NA · recruiting
NCT06546254 — 1% Lidocaine Paracervical Block for Endometrial Biopsy · NA · completed
NCT06733701 — The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02615340 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mount Sinai Hospital, Canada
Last refreshed: 19 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02615340.

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