NCT03084029

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Jan 2016

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

April 15, 2016

Last Update Submit

February 4, 2018

Conditions

Healthy

Keywords

oxytocinfMRIempathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Behavioral ratings of subjective experienced empathy processing

    45-115 minutes after single dose administration

Study Arms (4)

male participants - oxytocin nasal spray

EXPERIMENTAL

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

Drug: Oxytocin

female participants - oxytocin nasal spray

EXPERIMENTAL

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

Drug: Oxytocin

male participants - placebo nasal spray

PLACEBO COMPARATOR

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

Drug: Placebo

female participants - placebo nasal spray

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OxytocinDRUG

40 international units

Also known as: Oxytocin Treatment
female participants - oxytocin nasal spraymale participants - oxytocin nasal spray
PlaceboDRUG

40 international units

Also known as: Placebo treatment
female participants - placebo nasal spraymale participants - placebo nasal spray

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Life Science and Technology,University of Electronic Science and Technology

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Keith Kendrick, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 15, 2016

First Posted

March 20, 2017

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)