NCT03128203

Brief Summary

To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state functional connectivity in healthy males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

April 20, 2017

Last Update Submit

April 20, 2017

Conditions

Healthy

Keywords

OxytocinResting-stateFunctional connectivityBOLD

Outcome Measures

Primary Outcomes (1)

  • Striatal functional connectivity alterations after drug administration

    fMRI-based resting state connectivity of the striatum will be compared between the oxytocin and the placebo group

    45 minutes after drug administration

Study Arms (2)

Oxytocin

EXPERIMENTAL
Drug: Oxytocin

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

OxytocinDRUG

Oxytocin, intranasally administrated

Oxytocin
PlacebosDRUG

Saline, intranasally administrated

Placebo

Eligibility Criteria

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

You may qualify if:

  • healthy subjects without past or current psychiatric or neurological disorders

You may not qualify if:

  • with MRI Contraindications

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

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Benjamin Becker, Dr.

    School of Life Science and Technology, 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

April 20, 2017

First Posted

April 25, 2017

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

CN(1)