NCT02536417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 29, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

4.2 years

First QC Date

August 10, 2015

Last Update Submit

August 24, 2021

Conditions

Delirium

Keywords

MelatoninDelirium preventionEnd-of-life

Outcome Measures

Primary Outcomes (1)

  • Development of delirium, as determined by the Confusion Assessment Method (CAM) criteria

    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.

    1 month

Study Arms (2)

Treatment arm: melatonin

ACTIVE COMPARATOR

melatonin 0.5 mg as treatment, to be given daily at bedtime

Drug: Melatonin

Placebo arm

PLACEBO COMPARATOR

Sugar pill identical in appearance to the melatonin 0.5 mg tablets used in treatment arm

Drug: Sugar pill

Interventions

MelatoninDRUG

To determine the effectiveness of melatonin in preventing the development of delirium compared with placebo

Also known as: Melatonin Brand: General Nutrition Center
Treatment arm: melatonin
Sugar pillDRUG

To determine if placebo effect plays a part in preventing the development of delirium

Also known as: Lactose pill
Placebo arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

MeSH Terms

Conditions

DeliriumDeath

Interventions

MelatoninSugarsLactose

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPathologic Processes

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCarbohydratesDisaccharidesOligosaccharidesPolysaccharides

Study Officials

  • David D Ng, PharmD

    Fraser Health

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Specialist

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 31, 2015

Study Start

June 29, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

CA(1)