The Role of Oxytocin in the Perception of Faces

NCT02443727 | Completed Early Phase 1 DMC

• 1 other identifier: STUDY00001225
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• Functional Magnetic Resonance Imaging (fMRI) Data

  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

  The effect of OT will be assessed by determining changes in eye movements between treatment and placebo groups.

  45 minutes after OT manipulation

Secondary Outcomes (2)

• Implicit Attitudes toward infants

  45 minutes after OT manipulation

• Theory of mind

  45 minutes after OT manipulation

Study Arms (2)

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).

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).

Other: Placebo

Interventions

Syntocinon (synthetic oxytocin) DRUG

Dosage and details described in arm.

Also known as: OT

Intranasal oxytocin group

Placebo OTHER

Dosage and details described in arm.

Placebo group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rodrigo Cardenas: lead
• U.S. National Science Foundation: collaborator

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rodrigo A Cardenas, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 25, 2023

Record last verified: 2023-04