Melatonin for Treatment of Delirium in Critically Ill Adult Patients

ConditionDelirium

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCiusss de L'Est de l'Île de Montréal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Melatonin
Drug
Study drug will be given at 21:00 daily, starting on the day of enrolment until delirium resolution, hospital discharge, death, or up to 14 days. The study medication will be given by mouth (PO or per os) or, if needed, via the feeding tube.
Placebo
Drug
Study drug will be given at 21:00 daily, starting on the day of enrolment until delirium resolution, hospital discharge, death, or up to 14 days. The study medication will be given by mouth (PO or per os) or, if needed, via the feeding tube.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Enteral melatonin 9 mgExperimental treatment 1 intervention

Group B: Enteral placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility: Enrollment rate

Average enrollment rate of participants per month.

Time frame

8 months

Clinical: Duration of delirium

Compare the average duration of an episode of delirium defined as the number of days with ICDSC score ≥4 between the 2 groups.

Time frame

14 days

Secondary outcomes

Feasibility: Study adherence

Proportion of administered doses in the prescribed dose administration window (between 19:00 and 23:00 hours) divided by total number of eligible study days.

Time frame

8 months

Feasibility: Consent rate

Proportion of participants recruited among eligible patients.

Time frame

8 months

Clinical: Adverse events

Incidence of adverse events reported in the Canadian melatonin monograph (i.e. headache and nausea) observed by the investigators or reported by the treating team.

Time frame

14 days

Other outcomes

Feasibility: Completion of study

Proportion of participants who completed the study and reasons associated with withdrawal.

Time frame

8 months

Feasibility: MDAS assessment time (minutes)

Time required for the administration of the Memorial Delirium Assessment Scale (MDAS). Values from 0 to 30. A higher score means a worse outcome.

Time frame

8 months

Feasibility: Completion of ICDSC

Proportion of missing data in the completion of the Intensive Care Delirium Screening Checklist (ICDSC). Values from 0 to 8. A higher score means a worse outcome.

Time frame

8 months

Clinical: Antipsychotics dose (mg) administered to participants

Cumulative dose of de novo antipsychotics, reported in haloperidol equivalent dose, received by participants during delirium.

Time frame

14 days