Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000362594
Ethics application status
Approved
Date submitted
16/08/2006
Date registered
21/08/2006
Date last updated
21/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Oxytocin facilitate memory and attraction to human faces.
Scientific title
A randomised controlled trial to evaluate the effect of Oxytocin on the exposure to human faces to enhance memory and attraction ratings to human faces in healthy subjects.
Secondary ID [1] 297 0
Human Research Ethics Committee (HREC): HREC06074
Secondary ID [2] 298 0
Clinical Trial Notification (CTN): CTN 2006/314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 1331 0
Condition category
Condition code
Mental Health 1419 1419 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are given 24 IU Oxytocin or Placebo (Both Nasal Sprays) and exposed to pictures of human faces. Participants must make attraction and critical ratings of faces. They then return the next day while we assess their memory for the faces and, again, their attaction to faces that were presented the day before and new faces.
Intervention code [1] 1312 0
Treatment: Drugs
Comparator / control treatment
Participants are given either Placebo (Both Nasal Sprays) and exposed to pictures of human faces.
Control group
Placebo

Outcomes
Primary outcome [1] 1940 0
We assess participants recollection of facial expressions and how much they feel attracted to faces
Timepoint [1] 1940 0
The day after Oxytocin administration.
Secondary outcome [1] 3401 0
Whether participants can tell whether they have taken Oxytocin or a Placebo.
Timepoint [1] 3401 0
Participants are assessed the day of and after Oxytocin administration.

Eligibility
Key inclusion criteria
University students.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, epilepsy, substance abuse/ dependence, psychotic symptoms, suicidal thoughts. Participants are also instructed not to drink alcohol, caffeine or take any illegal drugs on the day of OT administration, and to abstain from fluids and food, except water, two hours before OT administration.

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)
Allocation concealment was conducted by labelling drug containers from 1 to 200.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All subjects, therapists and data entry staff are blind to drug condition.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1551 0
University
Name [1] 1551 0
University of New South Wales
Country [1] 1551 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1364 0
None
Name [1] 1364 0
None
Address [1] 1364 0
Country [1] 1364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2981 0
University of New South Wales
Ethics committee address [1] 2981 0
Ethics committee country [1] 2981 0
Date submitted for ethics approval [1] 2981 0
Approval date [1] 2981 0
Ethics approval number [1] 2981 0
06074

Summary
Brief summary
This study tests whether oxytocin facilitates the processing of human faces by enhancing memory and attractiveness towards exposed faces. Participants are assigned to Oxytocin or Placebo and then given a presentation of facial expressions. Participants must rate the attractiveness of each face. The next day, participants return to be assessed for their memory of faces and their attractiveness toward each face. THe hypothesis is that participants who were exposed to facial expressions with oxytocin will demonstrate better memory and greater attractiveness rating for these faces the next day than participants assigned to placebo. All participants, assessors, and research staff handling data are blind to condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27919 0
Address 27919 0
Country 27919 0
Phone 27919 0
Fax 27919 0
Email 27919 0
Contact person for public queries
Name 10501 0
Dr Adam Guastella
Address 10501 0
School of Psychology
University of New South Wales
Kensignton, NSW 2052.
Country 10501 0
Australia
Phone 10501 0
02 9385 8071
Fax 10501 0
Email 10501 0
[email protected]
Contact person for scientific queries
Name 1429 0
Dr Adam Guastella
Address 1429 0
School of Psychology
University of New South Wales
Kensignton, 2052.
Country 1429 0
Australia
Phone 1429 0
02 9385 8071
Fax 1429 0
Email 1429 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe promise and pitfalls of intranasally administering psychopharmacological agents for the treatment of psychiatric disorders.2016https://dx.doi.org/10.1038/mp.2015.166
N.B. These documents automatically identified may not have been verified by the study sponsor.