Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001537347
Ethics application status
Approved
Date submitted
31/10/2017
Date registered
6/11/2017
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Melatonin to treat Delirium in Older People
Scientific title
Melatonin to reduce sedative use in older general medical inpatients with delirium
Secondary ID [1] 293246 0
CTN 04006-1
Universal Trial Number (UTN)
U1111-1204-5084
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 305294 0
Condition category
Condition code
Neurological 304599 304599 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Melatonin 2mg oral capsule nightly for 7 nights administered by hospital nursing staff.
Intervention code [1] 299508 0
Treatment: Drugs
Comparator / control treatment
Placebo. An oral capsule identical to the melatonin capsule containing methylcellulose powder as placebo nightly for 7 nights administered by hospital nursing staff.
Control group
Placebo

Outcomes
Primary outcome [1] 303826 0
Dose of sedatives used (antipsychotic and benzodiazepine medication) using defined daily dose (DDD). DDD is the assumed average maintenance dose per day for a drug used for its main indications in adults and is used to standardise the comparison of drug usage between different medications.
Timepoint [1] 303826 0
Average defined daily dose of antipsychotic and benzodiazepine medication over the 7 day treatment period.
Secondary outcome [1] 340229 0
Delirium severity as measured using the Memorial Delirium Assessment Scale.
Timepoint [1] 340229 0
Average delirium severity score over the 7 day treatment period.

Eligibility
Key inclusion criteria
Diagnosis of delirium (regardless of cause) admitted to general medicine unit at Alfred Health
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently use of melatonin
Current use of antipsychotic or benzodiazepine medication
Allergy to melatonin
Unable to swallow capsule

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Basic description summaries of data will be performed (mean, standard deviation, median, interquartile range or n(%) as appropriate) and assessed for normality. Differences in continuous and categorical outcome variables between those in the placebo and melatonin groups will be assessed using parametric or non-parametric tests as appropriate. To assess each of the aims, univariate analysis will be performed for all variables to assess for difference between the melatonin and the placebo group. For the continuous variables, a student t-test will be used for parametric data and Mann-Whitney U test for non-parametric data. Differences in categorical variables will be reported using chi-square analysis. Multivariable analysis will be performed using linear regression for any of the significant outcome variables and potential confounding variables identified in the univariate analysis. A p-value threshold of < 0.05 will be used to denote statistical significance.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study designed and funded to recruit for 3 months. No further funds available for ongoing recruitment.
Date of first participant enrolment
Anticipated
4/12/2017
Actual
28/11/2017
Date of last participant enrolment
Anticipated
Actual
31/01/2018
Date of last data collection
Anticipated
Actual
7/02/2018
Sample size
Target
50
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9303 0
The Alfred - Prahran
Recruitment postcode(s) [1] 17971 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 297875 0
Hospital
Name [1] 297875 0
Caufield Hospital
Country [1] 297875 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Alfred Health, 55 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 296925 0
None
Name [1] 296925 0
Address [1] 296925 0
Country [1] 296925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298925 0
Alfred Health
Ethics committee address [1] 298925 0
55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 298925 0
Australia
Date submitted for ethics approval [1] 298925 0
21/09/2017
Approval date [1] 298925 0
05/10/2017
Ethics approval number [1] 298925 0
423/17

Summary
Brief summary
Delirium is an acute confusional state that is a medical emergency and is associated with significant morbidity and mortality. Delirium can often disrupt the times when someone is sleeping or awake. Although the main management of delirium is based on treatment of the underlying causes, specific medications are sometimes necessary to manage delirium-related behaviours. These interventions include the use of sedating medications that are associated with an increased risk of substantial harm.

Melatonin is a natural-occurring substance made in the brain that helps regulate the timing of sleep and wakefulness. It is a well-established treatment for insomnia, has a good safety profile and has a potential theoretical benefit in the management of delirium by correcting the sleep-wake cycle disruption commonly seen in delirium. Although it has been used to manage delirium in hospitals around the world for some years, there have been no scientific trials to examine its effectiveness. Melatonin is approved in Australia to treat insomnia. However it is not approved to manage delirium. Therefore, it is an experimental treatment for delirium. This means that it must be tested to see if it is an effective treatment for delirium.

This study aims to examine the effect of melatonin on delirium.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78670 0
Dr Chris Moran
Address 78670 0
Alfred Health,
55 Commercial Road,
Melbourne VIC 3004
Country 78670 0
Australia
Phone 78670 0
+61(3)90762000
Fax 78670 0
Email 78670 0
[email protected]
Contact person for public queries
Name 78671 0
Dr Chris Moran
Address 78671 0
Alfred Health,
55 Commercial Road,
Melbourne VIC 3004
Country 78671 0
Australia
Phone 78671 0
+61(3)90762000
Fax 78671 0
Email 78671 0
[email protected]
Contact person for scientific queries
Name 78672 0
Dr Chris Moran
Address 78672 0
Alfred Health,
55 Commercial Road,
Melbourne VIC 3004
Country 78672 0
Australia
Phone 78672 0
+61(3)90762000
Fax 78672 0
Email 78672 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.