Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department
1 other identifier
interventional
145
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2019
CompletedFirst Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedDecember 5, 2019
December 1, 2019
5 months
December 3, 2019
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Delirium
Diagnosis based Confusional Assessment Method Scale
14 days
Study Arms (2)
Melatonin 5mg
EXPERIMENTALMelatonin 5mg, every 24 hours for 14 days
Placebo
PLACEBO COMPARATORStarch based placebo, every 24 hours for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Mexicano Del Seguro Social
San Luis Potosí City, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 5, 2019
Study Start
October 10, 2019
Primary Completion
March 1, 2020
Study Completion
May 1, 2020
Last Updated
December 5, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share