Trial Review

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


Registration number
ACTRN12618001343291
Ethics application status
Approved
Date submitted
30/06/2018
Date registered
9/08/2018
Date last updated
9/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxytocin's role in social cognitive changes in ageing
Scientific title
Examining the effects of acute administration of intranasal oxytocin on emotion recognition and related social cognitive functions in healthy ageing
Secondary ID [1] 295317 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 308511 0
Cognition 308512 0
Condition category
Condition code
Mental Health 307483 307483 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will administer an acute (single) dose of oxytocin (24 IU) nasal spray, once off. Administration of the nasal spray will be guided by the researcher on the day of testing to ensure consistency in the administration of the intervention. Given the study involves a cross-over placebo-controlled design, there will be a washout period of approximately 4 weeks between active (oxytocin) and placebo testing sessions. The 4 weeks allow for the control of menstrual cycle effects in females.
Intervention code [1] 301645 0
Treatment: Drugs
Comparator / control treatment
Placebo nasal spray (saline solution without the active/peptide ingredient).
Control group
Placebo

Outcomes
Primary outcome [1] 306466 0
We will test the effects of intranasal oxytocin (vs. placebo) on the performance on a computerised Emotion Recognition Task in older compared to young adults. This task was designed specifically for this study using the FACES stimuli set, and by reducing the intensity of these stimuli to 50% and 75%.
Timepoint [1] 306466 0
The data will be collected post the administration of the treatment (oxytocin or placebo) in the 45-80 minutes post drug administration. The Emotion Recognition Task will be administered once during this time period - order is randomised with the rest of the tasks in the cognitive assessment battery. Results will be analysed post all data collection, i.e., at the completion of the data collection.
Secondary outcome [1] 348628 0
We will test the effects of intranasal oxytocin (vs. placebo) on the performance on a computerised theory of mind task (Reading the Mind in the Eyes Test) in older compared to young adults.
Timepoint [1] 348628 0
The data will be collected post the administration of the treatment (oxytocin or placebo) in the 45-80 minutes post drug administration. The Reading the Mind in the Eyes Test will be administered once during this time period - order is randomised with the rest of the tasks in the cognitive assessment battery. Results will be analysed post all data collection, i.e., at the completion of the data collection.

Eligibility
Key inclusion criteria
Participants will be young (18-30 years) and older adults (65-90 years), gender balanced, recruited from the general population. Older adults will also need to pass a well-validated dementia screening assessment involving the Telephone Interview for Cognitive Status .
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Since we are interested in examining social cognitive function in the context of normal ageing, we will exclude, for both groups, anyone with neurological/psychiatric illness, substance abuse or dependence, current use of antidepressants or anti-psychotics, history of heart disease, currently smoking, and pregnancy/lactating.

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)
Randomised allocation, numbered bottles
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
This study involves a randomised crossover study design where all participants will receive oxytocin and placebo across two testing sessions (repeated measures).
Phase
Phase 2 / Phase 3
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/07/2016
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
14/12/2018
Actual
Sample size
Target
120
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299907 0
University
Name [1] 299907 0
Australian Catholic University Research Fund
Country [1] 299907 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Young St, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 299274 0
None
Name [1] 299274 0
Address [1] 299274 0
Country [1] 299274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300776 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 300776 0
Australian Catholic University
115 Victoria Parade
Fitzroy, VIC 3065
Ethics committee country [1] 300776 0
Australia
Date submitted for ethics approval [1] 300776 0
Approval date [1] 300776 0
06/10/2015
Ethics approval number [1] 300776 0
2015-185H

Summary
Brief summary
The proposed research broadly aims to examine social cognitive changes and neuropeptide mechanisms in healthy older (vs. young) adults. This involves testing the effects of a small dose of acute intranasal OT (relative to placebo) on core social cognitive functions (e.g., emotion recognition, theory of mind), and to test if normal adult ageing is associated with changes in baseline levels of oxytocin and related hormones. We also explore whether individuals' level of functioning influence any of relationships between social cognition and oxytocin.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2826 2826 0 0
/AnzctrAttachments/375431-2015-185H Ethics application approval email.pdf (Ethics approval)

Contacts
Principal investigator
Name 84782 0
Dr Izelle Labuschagne
Address 84782 0
Australian Catholic University
Level 5, Daniel Mannix Building
Young St, Fitzroy, VIC 3065
Country 84782 0
Australia
Phone 84782 0
+61399533816
Fax 84782 0
Email 84782 0
[email protected]
Contact person for public queries
Name 84783 0
Dr Izelle Labuschagne
Address 84783 0
Australian Catholic University
Level 5, Daniel Mannix Building
Young St, Fitzroy, VIC 3065
Country 84783 0
Australia
Phone 84783 0
+61399533816
Fax 84783 0
Email 84783 0
[email protected]
Contact person for scientific queries
Name 84784 0
Dr Izelle Labuschagne
Address 84784 0
Australian Catholic University
Level 5, Daniel Mannix Building
Young St, Fitzroy, VIC 3065
Country 84784 0
Australia
Phone 84784 0
+61399533816
Fax 84784 0
Email 84784 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23653Ethical approval    375431-(Uploaded-19-10-2020-15-20-00)-Study-related document.pdf
23654Study protocol    Available in study online files
23655Informed consent form    Available in study online files

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4087Plain language summaryNo The results from this study have been submitted in... [More Details]

Documents added automatically
No additional documents have been identified.