What side effects are associated with this type of intervention?

Melatonin, used for treating delirium, is known for its sedating effects with fewer psychomotor impairments compared to midazolam. It is less likely to cause amnesia and results in shorter postoperative recovery times. However, melatonin may be more effective in females and less effective in older adults undergoing surgery. Other treatments for delirium, such as benzodiazepines, can cause significant sedation, amnesia, and longer recovery times. Beta-blockers, gabapentin, and pregabalin are also used but have limited clinical experience in treating procedural anxiety and delirium.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of delirium. Management typically involves addressing the underlying causes and providing supportive care. Melatonin, known for its role in regulating the sleep-wake cycle and its antioxidant properties, is being studied for its potential benefits in treating delirium, but it has not yet received FDA approval for this indication. Other treatments under investigation include antipsychotics and sedatives, but these are used off-label and come with significant risks and side effects.

What other types of research exist?

Ramelteon, a melatonin receptor agonist, is a promising alternative for delirium patients due to its potential to regulate the sleep-wake cycle and provide organ protection. Additionally, non-pharmacological approaches such as environmental restructuring, sleep hygiene education, and light therapy should be considered.

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Other

Melatonin for Delirium (DELIRE-ICU Trial)

Phase 2

Recruiting

Led By François Marquis, M.D., M.A.

Research Sponsored by Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months

Summary

This trial aims to test if melatonin can help reduce delirium in critically ill ICU patients by improving their sleep. Delirium is common in these patients, and there are no effective drug treatments currently available. By regulating sleep, melatonin might shorten the duration of delirium episodes. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle.

Who is the study for?

Adults over 18 in the ICU with a recent delirium score of at least 4, expected to stay in the ICU for more than 48 hours. Not eligible if they have severe brain injuries, major cognitive disorders, certain psychiatric diagnoses, seizures, coma, are pregnant or breastfeeding, took melatonin recently or can't take oral meds.

What is being tested?

The trial is testing whether giving melatonin to critically ill adults helps treat delirium compared to a placebo. It's set up as a small-scale study first to see if it's possible to do a larger one later.

What are the potential side effects?

While not specified here, common side effects of melatonin may include drowsiness, headache and mild dizziness. Since this is about feasibility, close monitoring will likely identify any other potential side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical: Duration of delirium

Feasibility: Enrollment rate

Secondary study objectives

Clinical: Adverse events

Feasibility: Consent rate

Feasibility: Study adherence

Other study objectives

Clinical: Antipsychotics dose (mg) administered to participants

Feasibility: Completion of ICDSC

Feasibility: Completion of study

+1 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Enteral melatonin 9 mgExperimental Treatment1 Intervention

Melatonin 9 mg from a 1 mg/mL oral suspension of melatonin in ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.

Group II: Enteral placeboPlacebo Group1 Intervention

ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for delirium include antipsychotics, benzodiazepines, and melatonin. Antipsychotics work by modulating neurotransmitter activity, particularly dopamine and serotonin, to reduce agitation and hallucinations. Benzodiazepines enhance the effect of the neurotransmitter GABA, providing sedative and anxiolytic effects. Melatonin, which is being studied for its potential in treating delirium, regulates the sleep-wake cycle and has antioxidant properties. This is particularly important for delirium patients as disrupted sleep and oxidative stress are key factors in the development and exacerbation of delirium. By improving sleep quality and reducing oxidative damage, melatonin may help mitigate the symptoms of delirium.

Progress in Research on the Effect of Melatonin on Postoperative Cognitive Dysfunction in Older Patients.