DeliriumPhase 4NCT02282241
Melatonin for Delirium Prophylaxis
A Phase 4 study testing Melatonin in people with Delirium, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age or greater
- Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients given once daily placebo (cellulose) orally in the evening, for 14 days. Receives: Other: Placebo |
| Melatonin | Experimental | Patients given once daily melatonin 1.5mg orally in the evening, for 14 days. Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 14 days
Secondary outcomes (4)
Confusion (Confusion Assessment Method scores)
Confusion Assessment Method scores.
Measured: Within 14 days
Mortality
Measured: Within 14 days
Use of restraints
Measured: Within 14 days
Code White (Violence)
Measured: Within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startFeb 2016
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Project never began
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Y Chan, University of British Columbia
- Investigators
- Peter KY Chan, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282241
- Sponsor's protocol ID
- H13-02843
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2014
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium
- ClinicalTrials.gov ID
- NCT02282241
- Acronym / sponsor ID
- H13-02843
- Conditions
- Delirium
- Keywords
- Melatonin, Sleep, Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project never began
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPatients given once daily placebo (cellulose) orally in the evening, for 14 days. |
| Melatonin | Experimental | Drug: MelatoninPatients given once daily melatonin 1.5mg orally in the evening, for 14 days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age or greater
- Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin | Drug | Melatonin |
| Placebo | Other | Placebo |
Primary outcome
Delirium (Confusion Assessment Method)
Time frame: Within 14 days
Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician.
4 secondary outcomes
Confusion (Confusion Assessment Method scores)
Time frame: Within 14 days
Mortality
Time frame: Within 14 days
Use of restraints
Time frame: Within 14 days
Code White (Violence)
Time frame: Within 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
Related trials for Delirium
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter KY Chan, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin in people with Delirium, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (Confusion Assessment Method) (time frame: Within 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.