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Clinical Trials/NCT03084029
NCT03084029CompletedEarly Phase 1

The Neural Basis of Oxytocin's Effects on Empathy

University of Electronic Science and Technology of China1 site in 1 country72 target enrollmentStarted: January 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
Neural processing of empathy as assessed using fMRI

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

male participants - oxytocin nasal spray

Experimental

male participants - receiving a single dose of 40 IU intranasal oxytocin

Intervention: Oxytocin (Drug)

female participants - oxytocin nasal spray

Experimental

female participants - receiving a single dose of 40 IU intranasal oxytocin

Intervention: Oxytocin (Drug)

male participants - placebo nasal spray

Placebo Comparator

male participants - receiving a single dose of 40 IU intranasal placebo

Intervention: Placebo (Drug)

female participants - placebo nasal spray

Placebo Comparator

female participants - receiving a single dose of 40 IU intranasal placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Neural processing of empathy as assessed using fMRI

Time Frame: 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 Outcomes

  • Behavioral ratings of subjective experienced empathy processing(45-115 minutes after single dose administration)

Investigators

Sponsor
University of Electronic Science and Technology of China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Keith Kendrick

PhD

University of Electronic Science and Technology of China

Study Sites (1)

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