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Prevention of Delirium in Inpatients Utilizing Melatonin

NCT02654314 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2022-03-21

Study results available
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Summary

A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.

Conditions

  • Delirium

Interventions

DRUG

Melatonin

5 mg Melatonin nightly, beginning within 24 hours of admission

OTHER

Placebo

Blue capsule matching the melatonin arm

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Stephen A Atlas, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-11-03
Completion
2017-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654314 on ClinicalTrials.gov