Prevention of Delirium in Inpatients Utilizing Melatonin

Delirium Clinical Trial

— PODIUM  

Official title:

Prevention of Delirium in Inpatients Utilizing Melatonin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02654314
• Other study ID #: 1601017038
• Status: Terminated
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: November 3, 2017

Study information

• Verified date: March 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 277
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Melatonin
5 mg Melatonin nightly, beginning within 24 hours of admission

Other:
• Placebo
Blue capsule matching the melatonin arm

Locations

Country	Name	City	State
United States	Yale New Haven Hospital, Saint Raphael Campus	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Erratum in: Int J Geriatr Psychiatry. 2014 May;29(5):550. — View 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. Review. — View 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. — View 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. — View Citation

Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. Review. Erratum in: N Engl J Med. 2006 Apr 13;354(15):1655. — View Citation

Miller MO. Evaluation and management of delirium in hospitalized older patients. Am Fam Physician. 2008 Dec 1;78(11):1265-70. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	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	Length of Hospital Stay	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
Secondary	Days Utilizing Restraints	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
Secondary	Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.	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