HealthyEarly Phase 1NCT02443727
The Role of Oxytocin in the Perception of Faces
A Early Phase 1 study testing Syntocinon (synthetic oxytocin) in people with Healthy, run by Rodrigo Cardenas.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Syntocinon (synthetic oxytocin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- History of seizures
- Neurological Disorder
- Previous head trauma
- Hypertension
- Cardiovascular Disease
- Claustrophobia
- ferrous metal in any part of the body
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Syntocinon (synthetic oxytocin), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon (synthetic oxytocin)Drug
Also called OT
Dosage and details described in arm.
PlaceboOther
Dosage and details described in arm.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal oxytocin group | Experimental | 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). Receives: Drug: Syntocinon (synthetic oxytocin) |
| Placebo group | Placebo comparator | 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging (fMRI) Data
The effect of OT will be assessed by determining changes in brain activation between treatment and placebo groups.
Measured: 45 minutes after OT manipulation
Eye movements data
The effect of OT will be assessed by determining changes in eye movements between treatment and placebo groups.
Measured: 45 minutes after OT manipulation
Secondary outcomes (2)
Implicit Attitudes toward infants
Implicit attitudes toward infants as measured by the Implicit Association Test
Measured: 45 minutes after OT manipulation
Theory of mind
Theory of mind as measured by the Reading the mind in the eyes test
Measured: 45 minutes after OT manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodrigo Cardenas
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor-investigator, Rodrigo Cardenas, Penn State University
- Investigators
- Rodrigo A Cardenas, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443727
- Sponsor's protocol ID
- STUDY00001225
- Status last verified
- Apr 2023
- First submitted
- 5 May 2015
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxytocin in the Perception of Infant Faces
- ClinicalTrials.gov ID
- NCT02443727
- Acronym / sponsor ID
- STUDY00001225
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Rodrigo CardenasUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal oxytocin group | Experimental | Drug: Syntocinon (synthetic oxytocin)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). |
| Placebo group | Placebo comparator | Other: PlaceboThe 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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntocinon (synthetic oxytocin)Also: OTDosage and details described in arm. | Drug | Intranasal oxytocin group |
| PlaceboDosage and details described in arm. | Other | Placebo group |
Primary outcome
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.
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.
2 secondary outcomes
Implicit Attitudes toward infants
Time frame: 45 minutes after OT manipulation
Theory of mind
Time frame: 45 minutes after OT manipulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo A Cardenas, PhD principal investigator
Penn State University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Syntocinon (synthetic oxytocin) in people with Healthy, run by Rodrigo Cardenas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Magnetic Resonance Imaging (fMRI) Data (time frame: 45 minutes after OT manipulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.