The Neural Basis of Oxytocin's Effects on Empathy

The main focus of this study is to examine oxytocin effects on behavioral and neural indices of empathy processing.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Oxytocin; Drug: Placebo

Detailed Description

The neuropeptide oxytocin (OXT) has been demonstrated to modulate empathy in previous behavioural studies. The present study aims at replicating previous findings on OXT on empathy as well as to determine the neural basis of these effects.

In a between-subject, randomized double-blind design, subjects will be either administered intranasal OXT or placebo nasal spray (40 IU). 45 minutes after administration subjects will undergo (fMRI) tasks of empathic processing.

During the tasks subjects will be shown empathy inducing stimuli, and the behavioral and neural response in terms of cognitive, emotional and indirect emotional empathy will be assessed.

Before the administration of treatment, validated questionnaires assessing potential confounding variables, such as depression (Becks Depression Inventory (BDI)) or mood (Positive And Negative Affect Scale (PANAS)) will be administered to the subjects.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • School of Life Science and Technology,University of Electronic Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects without past or current psychiatric or neurological disorders
• no smoking at least 12 hours before experiment
• no alcohol, coffee or other stimulant drinking at least 12 hours before experiment

Exclusion Criteria:

• mental implants
• pregnancy
• uterine cavity operations
• use of medication
• acute physical disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: male participants - oxytocin nasal spray; male participants - receiving a single dose of 40 IU intranasal oxytocin	Drug: Oxytocin; 40 international units; Other Names: Oxytocin Treatment
Experimental: female participants - oxytocin nasal spray; female participants - receiving a single dose of 40 IU intranasal oxytocin	Drug: Oxytocin; 40 international units; Other Names: Oxytocin Treatment
Placebo Comparator: male participants - placebo nasal spray; male participants - receiving a single dose of 40 IU intranasal placebo	Drug: Placebo; 40 international units; Other Names: Placebo treatment
Placebo Comparator: female participants - placebo nasal spray; female participants - receiving a single dose of 40 IU intranasal placebo	Drug: Placebo; 40 international units; Other Names: Placebo treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural processing of empathy as assessed using fMRI	Main effects of treatment and interaction between treatment effects and sex will be assessed on brain activity and connectivity in core regions of the empathy networks during processing of empathy inducing pictures	45-115 minutes after single dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral ratings of subjective experienced empathy processing	Main effects of treatment and interaction between treatment effects and sex will be assessed on subjective feelings of empathy (ratings on a Likert scale in response to empathy inducing pictures).	45-115 minutes after single dose administration

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China
• Investigators: Principal Investigator: Keith Kendrick, PhD, China,Sichuan, School of Life Science and Technology,University of Electronic Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 4, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: oxytocin; fMRI; empathy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: UESTC-neuSCAN-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No