Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients
|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
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: Melatonin Drug: Sugar pill||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Treatment arm: melatonin
melatonin 0.5 mg as treatment, to be given daily at bedtime
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536417
|Contact: David D Ng, PharmDemail@example.com|
|Contact: Neil Hilliard, MDfirstname.lastname@example.org|
|Principal Investigator:||David D Ng, PharmD||Fraser Health|