Actively Recruiting
Melatonin for Treatment of Delirium in Critically Ill Adult Patients
Led by Ciusss de L'Est de l'Île de Montréal · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
C
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor
M
Maisonneuve-Rosemont Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.
CONDITIONS
Official Title
Melatonin for Treatment of Delirium in Critically Ill Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older admitted to the intensive care unit
- Anticipated ICU stay greater than 48 hours
- ICDSC score of 4 or higher within 48 hours prior to randomization
You will not qualify if you...
- Known allergy or sensitivity to melatonin or ingredients in ORA-BLEND SF�ae
- Use of melatonin within 24 hours before randomization
- Severe structural brain injury, advanced neurodegenerative disease, hepatic encephalopathy, or severe major neurocognitive disorder
- Diagnosis of schizophrenia, bipolar disorder, psychotic depression, uremic encephalopathy, or alcohol withdrawal
- Active seizures, coma, aphasia, or severe intellectual disability
- Limited short-term vital prognosis
- Diagnosis of delirium before ICU admission
- Pregnancy or breastfeeding
- Absolute contraindication to receive enteral medication
- Inability to understand or speak English or French
- Total blindness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
Research Team
J
Johannie Beaucage-Charron, Pharm.D., M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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