The Neural Basis of Oxytocin's Effects on Empathy

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oxytocin; Drug: Placebo

• Registration Number: NCT03084029
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

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

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-04
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
female participants - oxytocin nasal spray	Oxytocin	female participants - receiving a single dose of 40 IU intranasal oxytocin
male participants - oxytocin nasal spray	Oxytocin	male participants - receiving a single dose of 40 IU intranasal oxytocin
male participants - placebo nasal spray	Placebo	male participants - receiving a single dose of 40 IU intranasal placebo
female participants - placebo nasal spray	Placebo	female participants - receiving a single dose of 40 IU intranasal placebo

Primary Outcome Measures

Name	Time	Method
Neural processing of empathy as assessed using fMRI	45-115 minutes after single dose administration	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

Secondary Outcome Measures

Name	Time	Method
Behavioral ratings of subjective experienced empathy processing	45-115 minutes after single dose administration	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).

Trial Locations

Locations (1)

School of Life Science and Technology,University of Electronic Science and Technology; 🇨🇳 Chengdu, Sichuan, China