Clinical trial NCT02654314: Prevention of Delirium in Inpatients Utilizing Melatonin
Official title: Prevention of Delirium in Inpatients Utilizing Melatonin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Delirium
Keywords: prevention; delirium; in-patients; melatonin,
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 277
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Delirium
timeFrame: length of hospitalization, not to exceed 14 days
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: from day of admission to completion of acute care, not to exceed 30 days
measure: Days Utilizing Restraints
timeFrame: length of hospitalization, not to exceed 14 days
measure: Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.
timeFrame: length of hospitalization, not to exceed 14 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital, Saint Raphael Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephen A Atlas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
citation: Miller MO. Evaluation and management of delirium in hospitalized older patients. Am Fam Physician. 2008 Dec 1;78(11):1265-70.
citation: de Jonghe A, Korevaar JC, van Munster BC, de Rooij SE. Effectiveness of melatonin treatment on circadian rhythm disturbances in dementia. Are there implications for delirium? A systematic review. Int J Geriatr Psychiatry. 2010 Dec;25(12):1201-8. doi: 10.1002/gps.2454.
citation: de Jonghe A, van Munster BC, Goslings JC, Kloen P, van Rees C, Wolvius R, van Velde R, Levi M, de Haan RJ, de Rooij SE; Amsterdam Delirium Study Group. Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial. CMAJ. 2014 Oct 7;186(14):E547-56. doi: 10.1503/cmaj.140495. Epub 2014 Sep 2.
citation: Sultan SS. Assessment of role of perioperative melatonin in prevention and treatment of postoperative delirium after hip arthroplasty under spinal anesthesia in the elderly. Saudi J Anaesth. 2010 Sep;4(3):169-73. doi: 10.4103/1658-354X.71132.
citation: Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15.
citation: Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320.