Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

This study evaluates the efficacy of melatonin 5mg in the prevention of Delirium in the older adults in emergency department. Half of the participants will receive melatonin 5mg and the other half will use a starch-based placebo.

Study Overview

• Status: Unknown
• Conditions: Delirium in Old Age
• Intervention / Treatment: Drug: Melatonin 5 mg

Detailed Description

Melatonia is useful for the treatment of sleep disorders due to the interruption of the circadian rhythm, secondary to alterations caused by the environment. The doses of 5 to 10mg oral or sublingual can improve the quality of the sleep-wake cycle and alertness in short-term use.

Mechanism of action of melatonin are:

1. Binding to membrane receptors: MT1 and MT2 coupled to G protein
2. - Union to nuclear receptors.
3. - Interaction with cytosolic proteins.
4. - Antioxidant of direct and indirect action.
5. - Interaction with mitochondria.

Melatonin circulates 80% bound to albumin and the rest in free form in plasma, 85-90% is metabolized by 6-hydroxymelatonin in the liver, which is then conjugated with sulfuric acid (70-80%) or glucuronic ( 5-3%), and is excreted in urine and feces.

Melatonin and its metabolites act as catalytic antioxidants to safeguard mitochondrial electron transfer reactions, therefore, increases the efficiency of energy metabolism. Melatonin synthesis decreases significantly as age progresses and changes in the circadian cycle have been associated with accelerated aging.

• Study Type: Interventional
• Enrollment (Anticipated): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatima A Sánchez, Doctor of medicinen; Phone Number: 4441777616; Email: alon118@hotmail.com
• Study Contact Backup: Name: Antonio Gordillo, PhD; Phone Number: 6688 4448262346; Email: gordillo@uaslp.mx

Study Locations

• Mexico
  • San Luis Potosí, Mexico
    • Recruiting
    • Instituto Mexicano del Seguro Social
    • Contact: Alberto Ruíz, Doctor of medicine; Phone Number: 4448216363; Email: betoruizm74@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women over 60 who enter the emergency department with a stay in the ward for more than 8 hours and who will remain hospitalized for more than 48 hours due to admission pathology.
• Patients who agree to participate in the study by signing an informed consent (Signature by patient and / or family member).

Exclusion Criteria:

• Patients with a history of dementia or previous neurological diseases.
• Patients with a history of psychiatric disorder.
• Patients diagnosed with any type of liver disease.
• Warfarin treatment.
• Delirium data on admission to the emergency department.
• Patients under invasive mechanical ventilation and sedation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin 5mg; Melatonin 5mg, every 24 hours for 14 days	Drug: Melatonin 5 mg; Placebo; Other Names: Cronocaps
Placebo Comparator: Placebo; Starch based placebo, every 24 hours for 14 days	Drug: Melatonin 5 mg; Placebo; Other Names: Cronocaps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Diagnosis based Confusional Assessment Method Scale	14 days

Collaborators and Investigators

• Sponsor: Universidad Autonoma de San Luis Potosí
• Investigators: Study Director: Antonio Gordillo, PhD, Universidad Autonoma de San Luis Potosí; Principal Investigator: Fatima A Sánchez, Doctor of medicine, Universidad Autonoma de San Luis Potosí

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Delirium; Emergencies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: UAutonomaSLP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No