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Trial registered on ANZCTR
Registration number
ACTRN12614000101684
Ethics application status
Approved
Date submitted
22/01/2014
Date registered
28/01/2014
Date last updated
7/11/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Melatonin vs. placebo for the symptoms of delirium in elderly medical inpatients
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Scientific title
A double blinded, randomised, placebo controlled pilot trial of moderate dose melatonin for the abatement and
treatment of delirium in elderly general medical inpatients.
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Secondary ID [1]
283966
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nil
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Universal Trial Number (UTN)
U1111-1152-4837
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Trial acronym
MFDAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
delirium
290994
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Condition category
Condition code
Neurological
291339
291339
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Melatonin 5mg oral capsule nightly for 5 days administered directly by hospital nursing staff.
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Intervention code [1]
288652
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Treatment: Drugs
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Comparator / control treatment
Placebo - identical capsule but for active ingredient.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Symptoms of delirium - Memorial Delirium Assessment Scale.
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Assessment method [1]
291330
0
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Timepoint [1]
291330
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Average during treatment assessed daily over the 5 day treatment period.
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Secondary outcome [1]
306534
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Symptoms of delirium - Memorial Delirium Assessment Scale.
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Assessment method [1]
306534
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Timepoint [1]
306534
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Following treatment cessation, on days 6 and 7 of the trial (medication on days 1-5)
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Eligibility
Key inclusion criteria
Diagnosis of delirium (regardless of cause)
Inpatient under general medicine of the The Royal Melbourne Hospital
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusively hypoactive delirium, recent stroke (<14 days), sensory impairment or dysphasia or language such that not evaluable, undergoing surgery, prognosis <7days, severe hepatic or renal failure, allergy or intolerance to melatonin or excipients.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Permuted block opaque envelopes with random allocation by trial pharmacist
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
n/a
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2014
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Actual
19/05/2014
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Date of last participant enrolment
Anticipated
19/01/2016
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Actual
27/07/2016
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Date of last data collection
Anticipated
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Actual
3/08/2016
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Sample size
Target
36
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
6889
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
7718
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3050 - Royal Melbourne Hospital
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Recruitment postcode(s) [2]
14557
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3050 - Parkville
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Funding & Sponsors
Funding source category [1]
288597
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Hospital
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Name [1]
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The Royal Melbourne Hospital
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Address [1]
288597
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Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3051
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Country [1]
288597
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Australia
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Primary sponsor type
Hospital
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Name
The Royal Melbourne Hospital
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Address
Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3051
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Country
Australia
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Secondary sponsor category [1]
287308
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None
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Name [1]
287308
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Address [1]
287308
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Country [1]
287308
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290461
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Melbourne Health HREC
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Ethics committee address [1]
290461
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Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3051
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Ethics committee country [1]
290461
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Australia
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Date submitted for ethics approval [1]
290461
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29/01/2014
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Approval date [1]
290461
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08/05/2014
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Ethics approval number [1]
290461
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2014.037
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Summary
Brief summary
This is a pilot trial testing the feasibility and participants required to test the hypothesis that melatonin 5mg capsule every night will decrease the symptoms of delirium in elderly medical inpatients.
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Trial website
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Trial related presentations / publications
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Public notes
n/a
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Contacts
Principal investigator
Name
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Dr Peter Lange
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Address
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c/o APU, Ground Floor,
The Royal Melbourne Hospital,
Grattan st,
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
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Country
45810
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Australia
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Phone
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+61393424835
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Fax
45810
0
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Email
45810
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[email protected]
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Contact person for public queries
Name
45811
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Dr Peter Lange
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Address
45811
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c/o APU, Ground Floor,
The Royal Melbourne Hospital,
Grattan st,
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
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Country
45811
0
Australia
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Phone
45811
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+61393424835
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Fax
45811
0
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Email
45811
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[email protected]
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Contact person for scientific queries
Name
45812
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Dr Peter Lange
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Address
45812
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c/o APU, Ground Floor,
The Royal Melbourne Hospital,
Grattan st,
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
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Country
45812
0
Australia
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Phone
45812
0
+61393424835
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Fax
45812
0
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Email
45812
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Moderate dose melatonin for the abatement and treatment of delirium in elderly general medical inpatients: study protocol of a placebo controlled, randomised, double blind trial.
2016
https://dx.doi.org/10.1186/s12877-016-0230-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
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