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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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

Enrollment (Anticipated)

252

Phase

  • Not Applicable

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 Contact Backup

Study Locations

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

17 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
Placebo nasal spray
40IU
Experimental: Oxytocin
Oxytoxin nasal spray
40IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45-115 minutes after administration
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
45-115 minutes after administration
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.
45-115 minutes after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45-115 minutes after administration
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.
45-115 minutes after administration
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.
45-115 minutes after administration
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.
45-115 minutes after administration
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)
45-115 minutes after administration

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

July 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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