Prevention of Delirium in Inpatients Utilizing Melatonin

NCT02654314 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 1601017038
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

prevention; delirium; in-patients; melatonin,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of Hospital Stay

  from day of admission to completion of acute care, not to exceed 30 days

• Days Utilizing Restraints

  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.

  length of hospitalization, not to exceed 14 days

Study Arms (2)

Melatonin

EXPERIMENTAL

5 mg Melatonin nightly, beginning within 24 hours of admission

Drug: Melatonin

Cellulose Microcrystylline

PLACEBO COMPARATOR

Blue capsule matching the melatonin arm

Other: Placebo

Interventions

Melatonin DRUG

5 mg Melatonin nightly, beginning within 24 hours of admission

Melatonin

Placebo OTHER

Blue capsule matching the melatonin arm

Also known as: Cellulose Microcrystylline

Cellulose Microcrystylline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Inpatient admission to a general internal medicine service

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital, Saint Raphael Campus

New Haven, Connecticut, 06511, United States

Location

Related Publications (7)

• Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.

  PMID: 16540616 BACKGROUND

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

  PMID: 19069020 BACKGROUND

• 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.

  PMID: 21086534 BACKGROUND

• 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.

  PMID: 25183726 BACKGROUND

• 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.

  PMID: 21189854 BACKGROUND

• 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.

  PMID: 20845391 BACKGROUND

• 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.

  PMID: 24554232 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Jesse S Reynolds
• Organization: Yale Center for Analytical Sciences

jesse.reynolds@yale.edu

(203) 785-5445

Study Officials

• Stephen A Atlas, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 13, 2016
• Study Start: July 1, 2016
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: March 21, 2022
• Results First Posted: February 12, 2019

Record last verified: 2022-03

Locations

US (1)