DeliriumPhase 3NCT00873379
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly
A Phase 3 study testing melatonin in people with Delirium, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo. 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
- 122 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Mar 2008
- Phase
- Phase 3
- 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
- Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.
Who cannot join
- Life expectancy less than 24 hours,
- Unable to communicate in English,
- Unable to take oral medications,
- Intracranial bleed or known seizure disorder,
- Markedly sub or supra-therapeutic INR while on warfarin, OR
- A known allergy to study tablet ingredients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDietary supplement
one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada
placeboDietary supplement
half a white placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Active comparator | .5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380) Receives: Dietary Supplement: melatonin |
| placebo | Placebo comparator | half a white placebo tablet Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirious using confusion assessment method (CAM)
Measured: days
Secondary outcomes (1)
MDAS (memorial delirium assessment scale)
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionMar 2008
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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Investigators
- Chris Brymer, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873379
- Sponsor's protocol ID
- R-07-314
- Other IDs
- 13426
- Status last verified
- Jul 2009
- First submitted
- 31 Mar 2009
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00873379
- Acronym / sponsor ID
- R-07-314
- Conditions
- Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 1 Apr 2009 (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.
122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.
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 |
|---|---|---|
| melatonin | Active comparator | Dietary Supplement: melatonin.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380) |
| placebo | Placebo comparator | Dietary Supplement: placebohalf a white placebo tablet |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.
Key exclusion criteria (6 listed)
- Life expectancy less than 24 hours,
- Unable to communicate in English,
- Unable to take oral medications,
- Intracranial bleed or known seizure disorder,
- Markedly sub or supra-therapeutic INR while on warfarin, OR
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 |
|---|---|---|
| melatoninone half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada | Dietary supplement | melatonin |
| placebohalf a white placebo tablet | Dietary supplement | placebo |
Primary outcome
delirious using confusion assessment method (CAM)
Time frame: days
1 secondary outcome
MDAS (memorial delirium assessment scale)
Time frame: days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Chris Brymer, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing melatonin in people with Delirium, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jul 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
delirious using confusion assessment method (CAM) (time frame: 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 Jul 2009.