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Oxytocin's Effect on Social Pain Empathy

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ClinicalTrials.gov Identifier: NCT03122067
Recruitment Status : Unknown
Verified February 2018 by Keith Kendrick, University of Electronic Science and Technology of China.
Recruitment status was:  Recruiting
First Posted : April 20, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Keith Kendrick, University of Electronic Science and Technology of China

Tracking Information
First Submitted Date  ICMJE April 17, 2017
First Posted Date  ICMJE April 20, 2017
Last Update Posted Date February 7, 2018
Actual Study Start Date  ICMJE January 10, 2017
Estimated Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Neural activity changes associated with oxytocin administration [ Time Frame: 45-60 minutes after drug administration ]
fMRI-assessed brain activity during observing other being socially excluded
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Behavioral changes associated with oxytocin administration: ball-tossing [ Time Frame: 45-60 minutes after drug administration ]
Number of tosses to the other players (the excluder, new player, or previously excluded player)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxytocin's Effect on Social Pain Empathy
Official Title  ICMJE Oxytocinergic Modulation of Perceived Social Exclusion
Brief Summary The aim of the present experiment is to examine oxytocin's behavioral and neural effects on social pain empathy
Detailed Description In the current study, the investigators plan to examine whether oxytocin modulates behavior and neural activity during observing another person being excluded in an online ball-tossing game (a modified cyberball paradigm).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: oxytocin treatment
    intranasal administration of oxytocin
  • Drug: placebo treatment
    intranasal administration of placebo
Study Arms  ICMJE
  • Experimental: oxytocin group
    male participants with oxytocin treatment
    Intervention: Drug: oxytocin treatment
  • Placebo Comparator: placebo group
    male participants with placebo treatment
    Intervention: Drug: placebo treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2018
Estimated Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy participants without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • history of head injury
  • medical or psychiatric illness
  • smoking or drinking 24 hours before experiment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03122067
Other Study ID Numbers  ICMJE UESTC-neuSCAN-33
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith Kendrick, University of Electronic Science and Technology of China
Study Sponsor  ICMJE University of Electronic Science and Technology of China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Kendrick, Dr. School of Life Science and Technology, University of Electronic Science and Technology of China
PRS Account University of Electronic Science and Technology of China
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP