NCT03128242

Brief Summary

This study aims to investigate oxytocin's effect on attentional bias training. Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral). Effects of the training will be assessed using an eye-tracking anti-saccade task.

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
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable healthy

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

November 25, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

April 17, 2017

Last Update Submit

October 26, 2018

Conditions

Healthy

Keywords

oxytocinattention biasattention trainingeye-tracking

Outcome Measures

Primary Outcomes (3)

  • Reaction time (RT) difference - oxytocin effects

    Difference before and after oxytocin administration: reaction time to negative and neutral stimuli in the dot-probe task

    Before drug administration (pre-treatment baseline) and 55 minutes after drug administration

  • Reaction time (RT) difference - training effects

    Difference before and after training: reaction time to negative and neutral stimuli in the dot-probe task

    Before drug administration - 55-90 minutes after drug administration

  • Saccade latency difference - training effects

    Difference before and after training in saccade latency in the anti-saccade task

    Before drug administration - 55-90 minutes after drug administration

Study Arms (2)

oxytocin group

EXPERIMENTAL

oxytocin treatment

Drug: Oxytocin

placebo group

PLACEBO COMPARATOR

placebo treatment

Drug: placebo

Interventions

OxytocinDRUG

intranasal administration of oxytocin (24IU)

oxytocin group
placeboDRUG

intranasal administration of placebo (24IU)

placebo group

Eligibility Criteria

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

You may qualify if:

  • male participants with elevated trait anxiety (\> 45 scores as assessed with the State and Trait Anxiety Inventory, Spielberger, 1983)
  • without past or current psychiatric or neurological disorders

You may not qualify if:

  • history of head injury
  • medical or psychiatric illness
  • smoking or drinking 24 hours before the experiment

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

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

Central Study Contacts

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 25, 2017

Study Start

November 25, 2016

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

CN(1)