Prevention of Delirium in Intensive Care by Melatonin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-05-20

Brief Summary

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This is a double-blind, randomized, placebo-controlled, Phase 2b/3 two-part adaptive clinical trial. The trial is designed to investigate the pharmacokinetics and the efficacy of multiple dosing regimens of melatonin and to confirm the efficacy and safety of one dosing regimen in prevention for delirium.

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Detailed Description

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Treatment of the study is a single daily fixed-hour (21h) dose of 15 mL of an oral syrup, at one of the 3 following concentrations of melatonin: 0 mg/ml i.e. 0 mg/day (placebo); 0.02 mg/ml, i.e. 0.3 mg/day (low dose of melatonin) or 0.2 mg/ml, i.e. 3 mg/day (high dose of melatonin). The three dosages will be identical in appearance and volume.Treatment will be administered up to Day-14 (or death or discharge if these occur before Day-14). Randomization will be stratified by center.

Conditions

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Mechanically Ventilated Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MELATONIN (LOW DOSE)

Daily administration of melatonin by enteral route at 0.3 mg/day (low dose arm), up to 14 days.

Group Type EXPERIMENTAL

MELATONIN (LOW DOSE)

Intervention Type DRUG

Enteral melatonin (0.3mg ) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

MELATONIN (HIGH DOSE)

Daily administration of melatonin by enteral route at 3 mg/day (high dose arm), up to 14 days.

Group Type EXPERIMENTAL

MELATONIN (HIGH DOSE)

Intervention Type DRUG

Enteral melatonin (3mg) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

PLACEBO

Daily administration of identical placebo up to 14 days.

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

Study drug will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days.

Interventions

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MELATONIN (HIGH DOSE)

Enteral melatonin (3mg) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

Intervention Type DRUG

MELATONIN (LOW DOSE)

Enteral melatonin (0.3mg ) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days

Intervention Type DRUG

PLACEBO

Study drug will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days.

Intervention Type DRUG

Other Intervention Names

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N-acetyl-5-methoxytryptamine N-acetyl-5-methoxytryptamine

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Patient under invasive mechanical ventilation
* Anticipated stay in intensive care unit of at least 48 hours
* Informed consent signed by the patient or a relative or emergency consent

Exclusion Criteria

* Invasive mechanical ventilation for more than 48 hours
* known pregnancy or breastfeeding
* No understanding of the French language, deafness
* Dementia (Mini Mental State \<20) or known chronic psychosis
* Delirium (positive CAM-ICU score) before or at the time of randomization
* Alcohol withdrawal syndrome before or at the time of randomization with Cushman score ≥5
* Inability to use the enteral route, food intolerance with vomiting
* Severe hepatic insufficiency (prothrombin level \<30%)
* Ongoing treatment with melatonin or a drug that interacts or modifies its metabolism (fluvoxamine, 5- or 8-methoxypsoralen, estrogen, cimetidine, carbamazepine, rifampicin)
* known allergy to melatonin
* moribund state
* Patient admitted to intensive care for cardiopulmonary arrest, stroke, head trauma, neurosurgery.
* Patient not affiliated to social security
* Patient participating in another interventional clinical study with melatonin and / or for whom delirium is the primary endpoint

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No