- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536417
Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients
Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients: A Randomized Double-blinded Placebo Controlled Pilot Study
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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British Columbia
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Surrey, British Columbia, Canada, V3V 1Z2
- Surrey Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment arm: melatonin
melatonin 0.5 mg as treatment, to be given daily at bedtime
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To determine the effectiveness of melatonin in preventing the development of delirium compared with placebo
Other Names:
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Placebo Comparator: Placebo arm
Sugar pill identical in appearance to the melatonin 0.5 mg tablets used in treatment arm
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To determine if placebo effect plays a part in preventing the development of delirium
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of delirium, as determined by the Confusion Assessment Method (CAM) criteria
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David D Ng, PharmD, Fraser Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Death
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- FHREB 2015-048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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