Prevention of Delirium in Inpatients Utilizing Melatonin
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 2/14/2019 |
| Start Date: | July 2016 |
| End Date: | November 3, 2017 |
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.
given to patients at least 65 years old, admitted to the hospital on a general medical floor,
to prevent delirium.
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.
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.
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
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