NCT03055546

Brief Summary

The aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Feb 2016

Longer than P75 for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

April 15, 2016

Last Update Submit

October 26, 2018

Conditions

Keywords

oxytocinemotion regulation

Outcome Measures

Primary Outcomes (1)

  • Oxytocin effects on neural activity during emotion regulation task

    Neural activity will be measured by functional magnetic resonance imaging (fMRI). Differences in activity of prefrontal cortex (PFC) and amygdala will be compared between oxytocin and placebo groups during emotional go-nogo task and cognitive reappraisal task.

    Between 45-110 minutes after the intranasal administration of oxytocin

Secondary Outcomes (4)

  • Oxytocin effects on heart rate variability during emotion regulation task

    Between 45-110 minutes after the intranasal administration of oxytocin

  • Oxytocin effects on behavior response during emotion regulation task

    Between 45-110 minutes after the intranasal administration of oxytocin

  • Oxytocin effects on heart rate variability during resting-state

    Between 35-45 minutes after the intranasal administration of oxytocin

  • Oxytocin effects on neural activity during resting-state

    Between 35-45 minutes after the intranasal administration of oxytocin

Study Arms (2)

Oxytocin

EXPERIMENTAL

intranasal administration of oxytocin

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

intranasal administration of placebo

Drug: Placebo

Interventions

intranasal administration of oxytocin

Also known as: Syntocinon
Oxytocin

intranasal administration of placebo

Also known as: Intranasal Placebo
Placebo

Eligibility Criteria

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

You may qualify if:

  • healthy subjects without past or current psychiatric or neurological disorders

You may not qualify if:

  • history of head injury;
  • claustrophobia;
  • medical or psychiatric illness.

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, 611731, China

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Keith Kendrick, Dr.

    University of Electronic Science and Technology of China

    STUDY DIRECTOR
  • Benjamin Becker

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weihua Zhao, Master

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Professor / Research group leader

Study Record Dates

First Submitted

April 15, 2016

First Posted

February 16, 2017

Study Start

February 1, 2016

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

October 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations