NCT03085628

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

March 2, 2017

Last Update Submit

February 6, 2018

Conditions

Mental Health Wellness 1Social BehaviorEmotion

Keywords

social sharingsocial rewardfunctional magnetic resonance imagingreward circuit

Outcome Measures

Primary Outcomes (3)

  • fMRI: neural activity during social reward processing

    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

    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

    Main effects of treatment will be analyzed on fMRI connectivity during a social reward processing paradigm.

    45-115 minutes after administration

Secondary Outcomes (5)

  • Behavior: arousal ratings during social reward processing

    45-115 minutes after administration

  • Behavior: valence rating during social reward processing

    45-115 minutes after administration

  • Modulatory effects of sex on arousal ratings during social reward processing

    45-115 minutes after administration

  • Modulatory effects of sex on valence ratings during social reward processing

    45-115 minutes after administration

  • Pre-treatment modulators: attachment style (AAS)

    45-115 minutes after administration

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytoxin nasal spray

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo nasal spray

Drug: Placebo

Interventions

OxytocinDRUG

40IU

Oxytocin
PlaceboDRUG

40IU

Placebo

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

school of life science and technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

Related Publications (1)

  • Ma X, Zhao W, Luo R, Zhou F, Geng Y, Xu L, Gao Z, Zheng X, Becker B, Kendrick KM. Sex- and context-dependent effects of oxytocin on social sharing. Neuroimage. 2018 Dec;183:62-72. doi: 10.1016/j.neuroimage.2018.08.004. Epub 2018 Aug 4.

    PMID: 30086408DERIVED

MeSH Terms

Conditions

Social Behavior

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Keith Kendrick, Dr

CONTACT

kkendrick@uestc.edu.cn

Benjamin Becker, Dr

CONTACT

ben_becker@gmx.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 21, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

CN(1)