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

Sponsor
Fraser Health (Other)
Overall Status
Completed
CT.gov ID
NCT02536417
Collaborator
(none)
19
1
2
50.1
0.4

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 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 :
Jun 29, 2016
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • Lactose pill
  • Outcome Measures

    Primary Outcome Measures

    1. Development of delirium, as determined by the Confusion Assessment Method (CAM) criteria [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surrey Memorial Hospital Surrey British Columbia Canada V3V 1Z2

    Sponsors and Collaborators

    • Fraser Health

    Investigators

    • Principal Investigator: David D Ng, PharmD, Fraser Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Ng, Clinical Pharmacy Specialist, Fraser Health
    ClinicalTrials.gov Identifier:
    NCT02536417
    Other Study ID Numbers:
    • FHREB 2015-048
    First Posted:
    Aug 31, 2015
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by David Ng, Clinical Pharmacy Specialist, Fraser Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 26, 2021