Effects of Intranasal Oxytocin on Emotion Regulation

October 26, 2018 updated by: Benjamin Becker, University of Electronic Science and Technology of China
The aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the present study, the investigators plan to conduct a between-subject, double-blind, placebo-controlled experiment to investigate the effects of oxytocin on neural, physiological and behavior activity related to emotion regulation. The emotion regulation ability will be assessed by emotional go-nogo task and cognitive reappraisal task. The neural activity will be explored by functional magnetic resonance imaging (fMRI). And the investigators will record participants' heart rate during fMRI to investigate the effects of oxytocin on heart rate variability in emotion regulation process.

All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety before self-administration, including Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and Buss shyness Scale (CBSS), Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ), Interpersonal Reactivity Index (IRI), Action Control Scale (ACS), Emotion Regulation Questionnaire (ERQ), Berkley Expressivity Questionnaire (BEQ), and so on.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • School of Life Science and Technology, University of Electronic Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
intranasal administration of placebo
Drug: Placebo
intranasal administration of placebo
Other Names:
  • Intranasal Placebo
Experimental: Oxytocin
intranasal administration of oxytocin
Drug: Oxytocin
intranasal administration of oxytocin
Other Names:
  • Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxytocin effects on neural activity during emotion regulation task
Time Frame: Between 45-110 minutes after the intranasal administration of oxytocin
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxytocin effects on heart rate variability during emotion regulation task
Time Frame: Between 45-110 minutes after the intranasal administration of oxytocin
The heart rate will be recorded during the fMRI. The effects of oxytocin will be assessed by determining changes in heart rate variability between oxytocin and placebo groups during emotional go-nogo task and cognitive reappraisal task.
Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on behavior response during emotion regulation task
Time Frame: Between 45-110 minutes after the intranasal administration of oxytocin
The effects of oxytocin will be assessed by determining changes in reaction time and accuracy during emotional go-nogo task and negative affect ratings during cognitive reappraisal task between oxytocin and placebo groups.
Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on heart rate variability during resting-state
Time Frame: Between 35-45 minutes after the intranasal administration of oxytocin
The heart rate will be recorded during the resting-state. The effects of oxytocin will be assessed by determining changes in heart rate variability between oxytocin and placebo groups during resting-state.
Between 35-45 minutes after the intranasal administration of oxytocin
Oxytocin effects on neural activity during resting-state
Time Frame: Between 35-45 minutes after the intranasal administration of oxytocin
The effects of oxytocin will be assessed by determining changes in neural activity between oxytocin and placebo groups during resting-state.
Between 35-45 minutes after the intranasal administration of oxytocin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Investigators

  • Study Director: Keith Kendrick, Dr., University of Electronic Science and Technology of China
  • Principal Investigator: Benjamin Becker, University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UESTC-neuSCAN-11

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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