The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
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
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.
Secondary ID [1] 283966 0
nil
Universal Trial Number (UTN)
U1111-1152-4837
Trial acronym
MFDAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delirium 290994 0
Condition category
Condition code
Neurological 291339 291339 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Melatonin 5mg oral capsule nightly for 5 days administered directly by hospital nursing staff.
Intervention code [1] 288652 0
Treatment: Drugs
Comparator / control treatment
Placebo - identical capsule but for active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 291330 0
Symptoms of delirium - Memorial Delirium Assessment Scale.
Timepoint [1] 291330 0
Average during treatment assessed daily over the 5 day treatment period.
Secondary outcome [1] 306534 0
Symptoms of delirium - Memorial Delirium Assessment Scale.
Timepoint [1] 306534 0
Following treatment cessation, on days 6 and 7 of the trial (medication on days 1-5)

Eligibility
Key inclusion criteria
Diagnosis of delirium (regardless of cause)
Inpatient under general medicine of the The Royal Melbourne Hospital
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
Permuted block opaque envelopes with random allocation by trial pharmacist
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block
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
n/a
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6889 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 7718 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 14557 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 288597 0
Hospital
Name [1] 288597 0
The Royal Melbourne Hospital
Address [1] 288597 0
Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3051
Country [1] 288597 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3051
Country
Australia
Secondary sponsor category [1] 287308 0
None
Name [1] 287308 0
Address [1] 287308 0
Country [1] 287308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290461 0
Melbourne Health HREC
Ethics committee address [1] 290461 0
Grattan street
THE ROYAL MELBOURNE HOSPITAL
VIC 3051
Ethics committee country [1] 290461 0
Australia
Date submitted for ethics approval [1] 290461 0
29/01/2014
Approval date [1] 290461 0
08/05/2014
Ethics approval number [1] 290461 0
2014.037

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.
Trial website
Trial related presentations / publications
Public notes
n/a

Contacts
Principal investigator
Name 45810 0
Dr Peter Lange
Address 45810 0
c/o APU, Ground Floor,
The Royal Melbourne Hospital,
Grattan st,
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
Country 45810 0
Australia
Phone 45810 0
+61393424835
Fax 45810 0
Email 45810 0
peter.lange@msn.com
Contact person for public queries
Name 45811 0
Dr Peter Lange
Address 45811 0
c/o APU, Ground Floor,
The Royal Melbourne Hospital,
Grattan st,
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
Country 45811 0
Australia
Phone 45811 0
+61393424835
Fax 45811 0
Email 45811 0
peter.lange@mh.org.au
Contact person for scientific queries
Name 45812 0
Dr Peter Lange
Address 45812 0
c/o APU, Ground Floor,
The Royal Melbourne Hospital,
Grattan st,
THE ROYAL MELBOURNE HOSPITAL
VIC 3050
Country 45812 0
Australia
Phone 45812 0
+61393424835
Fax 45812 0
Email 45812 0
peter.lange@mh.org.au