Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001148561
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
28/10/2015
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Date results information initially provided
5/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in ageing in healthy adults.
Scientific title
An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in ageing in healthy adults.
Secondary ID [1] 287177 0
Nil
Universal Trial Number (UTN)
U1111-1172-7351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nil - Healthy Ageing 295747 0
Condition category
Condition code
Neurological 296803 296803 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two acute treatment (24 IU each) conditions including; a) intranasal placebo, and b) intranasal oxytocin (Syntocinon, Novartis, Switzerland). The two treatment conditions will be separated by a minimum of 1 week (washout period). The nasal sprays will be administered 50 mins prior to the functional magnetic resonance (fMRI) protocol using a standard supervised dosage procedure that involves 3 sprays in each the left or right nostril (6 sprays total). The fMRI protocol will be 20mins in duration and involve showing participants a brief task involving pictures of human faces expressing different emotions. The MRI protocol will also involve taking structural, resting state images of the brain while the participant is not engaged in a task.
Intervention code [1] 292451 0
Treatment: Drugs
Comparator / control treatment
Placebo, a saline solution without the active (peptide) ingredient.
Young healthy adults (aged 18-39 years) will be compared to healthy older adults (60+ years)
Control group
Placebo

Outcomes
Primary outcome [1] 295694 0
Functional MRI (fMRI) data will be collected in response to an emotional face expression task. The fMRI data will be compared between the older and younger age groups for differences in brain response (e.g., in the amygdala) between placebo and oxytocin conditions.
Timepoint [1] 295694 0
The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.
Secondary outcome [1] 316243 0
Using the structural MRI data, the whole-brain structural differences n grey and white matter will be examined comparing the participants in the older and younger age groups to see if any structural brain differences are present.
Timepoint [1] 316243 0
The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.

Eligibility
Key inclusion criteria
Right-handed; non-smoker and no drug/alcohol abuse; medication free; no neurological disorders, and no metal objects present in body (or which can't be removed or which is not MRI safe).
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant medical or neurological condition, significant head injury (or loss of consciousness from longer than 5 mins), presence of ferrous-containing metals within the body, inability to tolerate small enclosed spaces without anxiety.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/10/2015
Date of last participant enrolment
Anticipated
31/12/2017
Actual
30/09/2019
Date of last data collection
Anticipated
Actual
30/10/2019
Sample size
Target
140
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291745 0
University
Name [1] 291745 0
Australian Catholic University Research Fund
Country [1] 291745 0
Australia
Primary sponsor type
University
Name
Australian Catholic University Research
Address
Level 5, Mannix Building, Young St, Fitzroy, Vic, 3065
Country
Australia
Secondary sponsor category [1] 290415 0
None
Name [1] 290415 0
Address [1] 290415 0
Country [1] 290415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293264 0
Australian Catholic University HREC
Ethics committee address [1] 293264 0
Level 5, Mannix Building, Young St, Fitzroy, Vic, 3065
Ethics committee country [1] 293264 0
Australia
Date submitted for ethics approval [1] 293264 0
23/07/2015
Approval date [1] 293264 0
10/10/2015
Ethics approval number [1] 293264 0
2015-181H

Summary
Brief summary
The overall aim of the current study is to examine social and emotional brain regions involved in healthy ageing using a double-blind placebo controlled intranasal oxytocin design and MRI techniques involving fMRI.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 609 609 0 0
/AnzctrAttachments/369025-2015-181H Ethics application approved!.pdf

Contacts
Principal investigator
Name 59158 0
Dr Izelle Labuschagne
Address 59158 0
Level 5, Daniel Mannix Building, Young St, Fitzroy, VIC 3065
Locked Bag 4115, Fitzroy MDC, VIC 3065
Country 59158 0
Australia
Phone 59158 0
+61 3 9953 3816
Fax 59158 0
Email 59158 0
izelle.labuschagne@acu.edu.au
Contact person for public queries
Name 59159 0
Miss Sally Grace
Address 59159 0
400B Burwood Road, Level 2
Swinburne University of Technology
Hawthorn, VIC 3122
Country 59159 0
Australia
Phone 59159 0
+61 3 9214 8415
Fax 59159 0
Email 59159 0
sgrace@swin.edu.au
Contact person for scientific queries
Name 59160 0
Miss Sally Grace
Address 59160 0
400B Burwood Road, Level 2
Swinburne University of Technology
Hawthorn, VIC 3122
Country 59160 0
Australia
Phone 59160 0
+61 3 9214 8415
Fax 59160 0
Email 59160 0
sgrace@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.