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Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536417
Recruitment Status : Unknown
Verified August 2017 by David Ng, Fraser Health.
Recruitment status was:  Recruiting
First Posted : August 31, 2015
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
David Ng, Fraser Health

Brief Summary:
The purpose of this study is to determine if melatonin administration to end-of-life patients is effective in preventing the development of delirium compared with those who do not receive this treatment. Delirium is a difficult to control symptom commonly seen in patients at the end-of-life. A person who is delirious is unable to think clearly and cannot make sense of what is going on around him/her.

Condition or disease Intervention/treatment Phase
Delirium Drug: Melatonin Drug: Sugar pill Phase 3

Detailed Description:

All patients over the age of 19 admitted to the tertiary palliative care unit and hospice residence who could meet the study requirements will be asked within 48 hours of admission for their interest in participating in the study. All those who interested in taking part will be referred to a research nurse for initial assessment for eligibility. For eligible patients who have consented to participate in the study, a research nurse who is not directly involved in the patient's care will approach the patient. A detailed subject information containing pertinent information on the study will be provided and ample time (up to 24 hours) will be given for consideration. The research nurse will explain the consent form to the patient and obtain consent signature if he/she agrees to participate. Once formal consent obtained, the eligible patient will be enrolled in the study.

Patients will be assigned randomly to one of the two arms of the study and receive nightly doses of melatonin 0.5 mg or placebo. Patients will be monitored for 14 days or until the development of delirium or the occurrence of death.

Patients will be assessed twice a day for delirium, around the end of each nursing shift, i.e. every 12 hours (at 0330 & 1530h) for fourteen consecutive days or until the development of delirium. The diagnostic tool used to detect delirium is the Confusion Assessment Method (CAM).

The primary outcome measure is incidence of delirium, defined according to the Confusion Assessment Method (CAM).

Data on harm will be collected. For example, adverse effects from melatonin such as excessive daytime drowsiness, headaches, nausea , transient depression have been reported in the medical literature. Patients will also be monitored closely for the development any of these adverse effects during the treatment period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients: A Randomized Double-blinded Placebo Controlled Pilot Study
Actual Study Start Date : June 29, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Treatment arm: melatonin
melatonin 0.5 mg as treatment, to be given daily at bedtime
Drug: Melatonin
To determine the effectiveness of melatonin in preventing the development of delirium compared with placebo
Other Name: Melatonin Brand: General Nutrition Center

Placebo Comparator: Placebo arm
Sugar pill identical in appearance to the melatonin 0.5 mg tablets used in treatment arm
Drug: Sugar pill
To determine if placebo effect plays a part in preventing the development of delirium
Other Name: Lactose pill




Primary Outcome Measures :
  1. Development of delirium, as determined by the Confusion Assessment Method (CAM) criteria [ Time Frame: 1 month ]
    The CAM diagnostic scale is a diagnostic instrument for identification of delirium for use in alert, non-intubated patients . It is a widely accepted and reliable tool for the detection of delirium in multiple clinical and research settings. The CAM method detects delirium using four key delirium criteria: (a) acute mental status change, (b) inattention, (c) disorganized thinking, and (d) altered level of consciousness. Delirium is diagnosed when criteria (a) and (b) plus either (c) or (d) are present.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to the test site
  • Adult patients over 19 years of age
  • Patients who can provide informed consent
  • Patients who are able to tolerate oral medications

Exclusion Criteria:

  • Patients with existing delirium or dementia on admission
  • Patients with poor clinical performance
  • Patients taking melatonin prior to admission
  • Patients taking medications that interact with melatonin
  • Patients who are unable to provide informed consent
  • Patients who are enrolled in any other research study involving drugs/devices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536417


Contacts
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Contact: David D Ng, PharmD 604-613-6438 david.ng@fraserhealth.ca
Contact: Neil Hilliard, MD neil.hilliard@fraserhealth.ca

Locations
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Canada, British Columbia
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: David Ng, PharmD    604-613-6438    david.ng@fraserhealth.ca   
Contact: Neil Hilliard, MD    604-851-4700 ext 642921    neil.hilliard@fraserhealth.ca   
Sponsors and Collaborators
Fraser Health
Investigators
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Principal Investigator: David D Ng, PharmD Fraser Health
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Responsible Party: David Ng, Clinical Pharmacy Specialist, Fraser Health
ClinicalTrials.gov Identifier: NCT02536417    
Other Study ID Numbers: FHREB 2015-048
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Keywords provided by David Ng, Fraser Health:
Melatonin
Delirium prevention
End-of-life
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants