NCT04493515

Brief Summary

The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate attention control using a social-emotional saccade/antisaccade eye-tracking paradigm.

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
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2020

Typical duration 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

First Submitted

Initial submission to the registry

July 27, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 27, 2020

Last Update Submit

July 27, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Effect of oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli

    Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions

    45 minutes - 100 minutes after treatment

  • Effect of oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli

    Comparison between social-specific error rates of saccade/antisaccade between the oxytocin and placebo treatment conditions.

    45 minutes - 100 minutes after treatment

Secondary Outcomes (2)

  • Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions

    45 minutes - 100 minutes after treatment

  • Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions

    45 minutes - 100 minutes after treatment

Study Arms (2)

Oral Oxytocin

EXPERIMENTAL

Oxytocin orally (24 IU)

Drug: Oral Oxytocin

Oral Placebo

PLACEBO COMPARATOR

Placebo orally (24 IU, identical ingredients, except the active agent)

Drug: Oral Placebo

Interventions

Administration of oxytocin orally (24 IU)

Oral Oxytocin

Administration of placebo orally (24 IU)

Oral Placebo

Eligibility Criteria

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

You may qualify if:

  • Male, healthy participants
  • Non smokers

You may not qualify if:

  • Previous or current medical, psychiatric, neurological disorder
  • Regular medication
  • Use of any psychoactive substances in the 24 hours before experiment
  • Contra-indications for oxytocin
  • Contra-indications for eye-tracking data acquisition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China(UESTC)

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

  • Keith Kendrick, PhD

    University of Electronic Science and Technology of China (UESTC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuang Qian, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2020

First Posted

July 30, 2020

Study Start

July 28, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations