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Sex- and Context-dependent Effects of Oxytocin on Social Reward Processing

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ClinicalTrials.gov Identifier: NCT03085628
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Electronic Science and Technology of China

Brief Summary:
The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences social reward processing and whether the effects are context- and sex-dependent.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Social Behavior Emotion Drug: Oxytocin Drug: Placebo Not Applicable

Detailed Description:

In a double-blind, randomized, placebo-controlled, between-subject design healthy volunteers will receive either oxytocin or placebo nasal spray (40IU in 10 puffs).

Subjects will come to the experiment in pairs (two friends of the same sex). 45 min after drug administration, the two subjects will simultaneously undergo a social reward task - during the task, functional magnetic resonance imaging (fMRI) data will be acquired from one of them. During the social reward task subjects will be asked to rate the valence and arousal of emotional pictures in three different conditions: alone, share with a stranger and share with their friend.

Before treatment, subjects will complete a range of validated questionnaires to control for potential confounders, such as level of depression (assessed using the BDI) and to explore associations between relevant personality factors and treatment effects, such as adult attachment style (assessed using the AAS).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Actual Study Start Date : July 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Oxytoxin nasal spray
Drug: Oxytocin
40IU

Placebo Comparator: Placebo
Placebo nasal spray
Drug: Placebo
40IU




Primary Outcome Measures :
  1. fMRI: neural activity during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Main effects of treatment will be analyzed on fMRI activity during a social reward processing paradigm.

  2. Modulatory effects of sex on fMRI based neural indices during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Interaction between treatment effects and sex will be analyzed on fMRI indices acquired during reward processing

  3. fMRI: functional connectivity during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Main effects of treatment will be analyzed on fMRI connectivity during a social reward processing paradigm.


Secondary Outcome Measures :
  1. Behavior: arousal ratings during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Main effects of treatment will be analyzed on behavioral ratings of arousal acquired during the social reward processing paradigm.

  2. Behavior: valence rating during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Main effects of treatment will be analyzed on behavioral ratings of valence acquired during the social reward processing paradigm.

  3. Modulatory effects of sex on arousal ratings during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Interactions between treatment and sex will be analyzed on behavioral arousal ratings acquired during the social reward processing paradigm.

  4. Modulatory effects of sex on valence ratings during social reward processing [ Time Frame: 45-115 minutes after administration ]
    Interactions between treatment and sex will be analyzed on behavioral valence ratings acquired during the social reward processing paradigm.

  5. Pre-treatment modulators: attachment style (AAS) [ Time Frame: 45-115 minutes after administration ]
    Associations between neural and behavioral effects of treatment with pre-treatment attachment style as assessed by the Adult Attachment Scale (AAS)



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Ages Eligible for Study:   17 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorder, right-handed, had normal or corrected-to normal vision.

Exclusion Criteria:

  • self-reported medication use, substance abuse, and presence of medical or psychiatric disorders

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): NCT03085628


Contacts
Contact: Keith Kendrick, Dr kkendrick@uestc.edu.cn
Contact: Benjamin Becker, Dr ben_becker@gmx.de

Locations
China, Sichuan
school of life science and technology, University of Electronic Science and Technology of China Recruiting
Chengdu, Sichuan, China, 611731
Contact: Qin Li, Master       helenlee@uestc.edu.cn   
Sponsors and Collaborators
University of Electronic Science and Technology of China

Responsible Party: University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT03085628     History of Changes
Other Study ID Numbers: UESTC-neuSCAN-08
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Electronic Science and Technology of China:
social sharing
social reward
functional magnetic resonance imaging
reward circuit

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs