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Melatonin for Delirium Prophylaxis

Primary Purpose

Delirium

Status

Withdrawn

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Melatonin

Placebo

About this trial

This is an interventional prevention trial for Delirium focused on measuring Melatonin, Sleep, Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

65 years of age or greater
Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards.

Exclusion Criteria:

those who are suspected to be delirious at the time of their initial presentation;
those who are already taking melatonin prior to admission;
those who are not expected to live more than 48 hours;
those suffering severe dementia (as indicated by a score of 6-7 on the Global Deterioration Scale adapted by Dr. Doug Drummond from Reisberg et al. (Reisberg 1982);
those who are unable to reliably take oral medications;
those presenting with an intracranial bleed, seizure or acute stroke;
those with a known allergy or adverse reaction to the study compounds;
those who cannot be evaluated initially because of depressed level of consciousness or inability to communicate;
those anticipated to require surgery early in their hospitalization.

Sites / Locations

Vancouver Coastal Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Melatonin

Arm Description

Patients given once daily placebo (cellulose) orally in the evening, for 14 days.

Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.

Outcomes

Primary Outcome Measures

Delirium (Confusion Assessment Method)

Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician.

Secondary Outcome Measures

Confusion (Confusion Assessment Method scores)

Confusion Assessment Method scores.

Mortality

Use of restraints

Code White (Violence)

Full Information

NCT ID

NCT02282241

First Posted

October 30, 2014

Last Updated

September 29, 2021

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02282241

Brief Title

Melatonin for Delirium Prophylaxis

Official Title

A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Project never began

Study Start Date

February 2016 (undefined)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Delirium is a common complication of illness especially among the elderly with serious sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric emergency has key features including acute onset, fluctuating level of consciousness, poor attention and cognitive deficits with a presentation which may include hallucinations and delusions. A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is a widely available natural health product with evidence in normalizing circadian rhythms and sleep. There is also preliminary evidence that melatonin can be used to prevent the development of delirium in hospitalized patients. We hypothesize that daily administration of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium

Keywords

Melatonin, Sleep, Delirium

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients given once daily placebo (cellulose) orally in the evening, for 14 days.

Arm Title

Melatonin

Arm Type

Experimental

Arm Description

Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Delirium (Confusion Assessment Method)

Description

Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician.

Time Frame

Within 14 days

Secondary Outcome Measure Information:

Title

Confusion (Confusion Assessment Method scores)

Description

Confusion Assessment Method scores.

Time Frame

Within 14 days

Title

Mortality

Time Frame

Within 14 days

Title

Use of restraints

Time Frame

Within 14 days

Title

Code White (Violence)

Time Frame

Within 14 days

Other Pre-specified Outcome Measures:

Title

Length of Stay

Time Frame

Within 6 months

Title

Time to delirium

Time Frame

Within 14 days

Title

Discharge Functional Status (Physiotherapist or Occupational therapist assessed)

Description

Physiotherapist or Occupational therapist assessed

Time Frame

Within 6 months

Title

Discharge Disposition (Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living)

Description

Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living

Time Frame

Within 6 months

Title

Sleep (Hours slept according to nursing records)

Description

Hours slept according to nursing records

Time Frame

Within 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 65 years of age or greater Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards. Exclusion Criteria: those who are suspected to be delirious at the time of their initial presentation; those who are already taking melatonin prior to admission; those who are not expected to live more than 48 hours; those suffering severe dementia (as indicated by a score of 6-7 on the Global Deterioration Scale adapted by Dr. Doug Drummond from Reisberg et al. (Reisberg 1982); those who are unable to reliably take oral medications; those presenting with an intracranial bleed, seizure or acute stroke; those with a known allergy or adverse reaction to the study compounds; those who cannot be evaluated initially because of depressed level of consciousness or inability to communicate; those anticipated to require surgery early in their hospitalization.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter KY Chan, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver Coastal Health

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

12. IPD Sharing Statement

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Melatonin for Delirium Prophylaxis

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