- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443727
The Role of Oxytocin in the Perception of Faces
April 22, 2023 updated by: Rodrigo Cardenas
The Role of Oxytocin in the Perception of Infant Faces
The main objective of this project is to study whether intranasal oxytocin (OT) affects how young adults perceive and attend to infant and adult faces.
Based on existing research the investigators predict that oxytocin will facilitate the allocation of attentional resources on infant faces (compared to adult faces).
The investigators also predict that oxytocin will enhance the activity of reward neural-networks associated with the perception of infant faces.
The behavioral effects of OT (visual attention and face recognition) will be measured with eye-tracking while participants look at photographs of adult and infant faces.
Neurological effects (the activity of emotion and reward networks) will be measured with functional Magnetic Resonance Imaging (fMRI) while participants look at infant faces on a computer screen.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy Volunteers
- Norma or corrected to norma vision
- Participants are non parents
- Able to provide written informed consent and to comply with all study procedures
Exclusion Criteria:
- Dementia or severe cognitive disorders
- Endocrine disease or malignancy
- Nasal obstruction or upper-respiratory tract infection
- Current or previous psychiatric disorder
- Current or previous use of psychoactive drugs
- Alcoholism or substance abuse
- History of seizures
- Neurological Disorder
- Previous head trauma
- Hypertension
- Cardiovascular Disease
- Claustrophobia
- ferrous metal in any part of the body
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intranasal oxytocin group
Participants will self-administer a single dose of 24 IU oxytocin (Syntocinon, Novartis; three puffs per nostril, each with 4 IU oxytocin, 6 puffs total).
|
Dosage and details described in arm.
Other Names:
|
Placebo Comparator: Placebo group
The placebo is identical to the oxytocin formulation with the exception of the active compound. Participants will self-administer three puffs per nostril of placebo (6 puffs total). |
Dosage and details described in arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Magnetic Resonance Imaging (fMRI) Data
Time Frame: 45 minutes after OT manipulation
|
The effect of OT will be assessed by determining changes in brain activation between treatment and placebo groups.
|
45 minutes after OT manipulation
|
Eye movements data
Time Frame: 45 minutes after OT manipulation
|
The effect of OT will be assessed by determining changes in eye movements between treatment and placebo groups.
|
45 minutes after OT manipulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implicit Attitudes toward infants
Time Frame: 45 minutes after OT manipulation
|
Implicit attitudes toward infants as measured by the Implicit Association Test
|
45 minutes after OT manipulation
|
Theory of mind
Time Frame: 45 minutes after OT manipulation
|
Theory of mind as measured by the Reading the mind in the eyes test
|
45 minutes after OT manipulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rodrigo A Cardenas, PhD, Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
May 5, 2015
First Submitted That Met QC Criteria
May 13, 2015
First Posted (Estimate)
May 14, 2015
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 22, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Syntocinon (synthetic oxytocin)
-
University of MinnesotaChildren's Hospital of PhiladelphiaWithdrawn
-
Uppsala UniversityCompletedMyocardial Ischemia | Hypotension | BloodlossSweden
-
Robert SchultzCompleted
-
University Hospital, ToulouseCompleted
-
Skane University HospitalCompletedPostprocedural Delayed Gastric Emptying
-
Stanford UniversityCompletedFragile X SyndromeUnited States
-
Evdokia AnagnostouThe Hospital for Sick Children; University of Illinois at Chicago; Holland Bloorview...CompletedAutism Spectrum DisorderCanada
-
Lawson Health Research InstituteThe Alzheimer Society London and MiddlesexCompletedFrontotemporal Dementia | Pick's DiseaseCanada
-
Skane University HospitalCompleted