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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03228901




Registration number
NCT03228901
Ethics application status
Date submitted
21/07/2017
Date registered
25/07/2017
Date last updated
27/07/2017

Titles & IDs
Public title
Oxytocin and Non-verbal Communication
Scientific title
Exploring the Effects of Oxytocin on Non-verbal Communication
Secondary ID [1] 0 0
IG15-B052
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Interaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oxytocin
Treatment: Drugs - Placebos

Experimental: Oxytocin - 24IU Syntocinon, delivered in a single nose via a nasal spray

Placebo Comparator: Placebo - Matched nasal spray


Treatment: Drugs: Oxytocin
Administration of the hormone oxytocin

Treatment: Drugs: Placebos
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non-verbal communication
Timepoint [1] 0 0
Measured in the interaction which commenced 45mins after drug administration
Secondary outcome [1] 0 0
Ratings of the person participants interacted with
Timepoint [1] 0 0
Measured following the interaction (which commenced 45 mins after drug administration)

Eligibility
Key inclusion criteria
- healthy
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- pregnant;

- history of epilepsy, severe depression, severe anxiety, or psychosis;

- smoking more than 15 cigarettes a day;

- addicted to illegal substances.

Study design
Purpose of the study
Basic Science
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2009
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Yale-NUS College
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this protocol registration, the investigators plan a secondary data analysis of a dataset
to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03228901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03228901