Clinical Trial: Prevention of Delirium in Inpatients Utilizing Melatonin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prevention of Delirium in Inpatients Utilizing Melatonin

Brief 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.

Detailed Summary:

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 two general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.

Within 24 hours of admission, 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 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.


Sponsor: Yale University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: January 8, 2016
Date Started: July 2016
Date Completion: May 2017
Last Updated: August 23, 2016
Last Verified: August 2016