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Effects of Intranasal Oxytocin on Emotion Regulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055546
Recruitment Status : Unknown
Verified October 2018 by Benjamin Becker, University of Electronic Science and Technology of China.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Becker, University of Electronic Science and Technology of China

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxytocin Drug: Placebo Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Intranasal Oxytocin on Emotion Regulation
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
intranasal administration of oxytocin
Drug: Oxytocin
intranasal administration of oxytocin
Other Name: Syntocinon

Placebo Comparator: Placebo
intranasal administration of placebo
Drug: Placebo
intranasal administration of placebo
Other Name: Intranasal Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055546


Contacts
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Contact: Weihua Zhao, Master zarazhao.uestc@outlook.com

Locations
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China, Sichuan
School of Life Science and Technology, University of Electronic Science and Technology Recruiting
Chengdu, Sichuan, China, 611731
Contact: Zhao Weihua       zarazhao.uestc@outlook.com   
Sponsors and Collaborators
University of Electronic Science and Technology of China
Investigators
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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
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Responsible Party: Benjamin Becker, Professor / Research group leader, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT03055546    
Other Study ID Numbers: UESTC-neuSCAN-11
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Becker, University of Electronic Science and Technology of China:
oxytocin
emotion regulation
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs