Prevention of Delirium in Inpatients Utilizing Melatonin (PODIUM)

March 10, 2022 updated by: Yale University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.

Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged.

Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale New Haven Hospital, Saint Raphael Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatient admission to a general internal medicine service

Exclusion Criteria:

  • expected lifespan or length of stay ≤ 48 hours
  • Non-English speaking
  • Already taking melatonin or ramelteon at the time of randomization
  • Presence of delirium at the time of randomization
  • Unable to take oral medications
  • Subject or proxy unable to provide informed consent within 18 hours of invitation or 24 hours of admission
  • ALT or AST (Liver function tests) > 3 times the upper limit of normal
  • Taking warfarin, nifedipine or fluvoxamine
  • Allergy to melatonin
  • Unable to recall 3 words after distraction by naming the days of the week backwards beginning with Sunday

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin
5 mg Melatonin nightly, beginning within 24 hours of admission
Drug: Melatonin
5 mg Melatonin nightly, beginning within 24 hours of admission
Placebo Comparator: Cellulose Microcrystylline
Blue capsule matching the melatonin arm
Other: Placebo
Blue capsule matching the melatonin arm
Other Names:
  • Cellulose Microcrystylline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium
Time Frame: length of hospitalization, not to exceed 14 days
Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization.
length of hospitalization, not to exceed 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: from day of admission to completion of acute care, not to exceed 30 days
Length of stay is defined as the total time hospitalized for the acute illness (in days).
from day of admission to completion of acute care, not to exceed 30 days
Days Utilizing Restraints
Time Frame: length of hospitalization, not to exceed 14 days
Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization.
length of hospitalization, not to exceed 14 days
Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.
Time Frame: length of hospitalization, not to exceed 14 days
Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization.
length of hospitalization, not to exceed 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Stephen A Atlas, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

November 3, 2017

Study Completion (Actual)

November 3, 2017

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1601017038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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