NCT04105140

Brief Summary

To investigate whether intranasal oxytocin (24 IU) treatment can influence prosocial learning behavior in males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2018

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 9, 2018

Last Update Submit

September 25, 2019

Conditions

Healthy

Keywords

oxytocinprosocial learning

Outcome Measures

Primary Outcomes (1)

  • Neural processing during feedback based on prosocial learning assessed by fMRI scanner

    fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment administrations.

    1 hour

Secondary Outcomes (1)

  • Behavioral learning performance measured by E-prime

    1 hour

Study Arms (2)

male oxytocin group

EXPERIMENTAL

male subjects with oxytocin treatment

Drug: Oxytocin

male placebo group

PLACEBO COMPARATOR

male subjects with placebo treatment

Drug: Placebo

Interventions

OxytocinDRUG

intranasal administration of oxytocin (24 IU)

male oxytocin group
PlaceboDRUG

intranasal administration of placebo (24 IU)

male placebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • without past or current psychiatric or neurological disorders

You may not qualify if:

  • history of head injury
  • medical or psychiatric illness

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, China

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Keith Kendrick, Dr.

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 26, 2019

Study Start

January 1, 2018

Primary Completion

August 10, 2018

Study Completion

August 10, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

CN(1)