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New treatment option for Delirium
Official title Melatonin for Treatment of Delirium in Critically Ill Adult Patients
ClinicalTrials.gov ID: NCT05713877
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for delirium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 years or older admitted to the intensive care unit;
- Anticipated ICU stay \> 48 hours;
- ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.
You likely can't join if
- Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®;
- Use of melatonin within 24 hours prior to randomization;
- Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced...
- Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal;
- Presence of active seizures, coma, aphasia or severe intellectual disability;
- Limited short-term vital prognosis;
See the full eligibility criteria
- Patients aged 18 years or older admitted to the intensive care unit;
- Anticipated ICU stay \> 48 hours;
- ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.
- Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®;
- Use of melatonin within 24 hours prior to randomization;
- Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy;
- Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal;
- Presence of active seizures, coma, aphasia or severe intellectual disability;
- Limited short-term vital prognosis;
- Diagnosis of delirium prior to ICU admission;
- Pregnancy or breastfeeding;
- Absolute contraindication to receive enteral medication;
- Inability to understand or speak English or French;
- Total blindness.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.