NCT03293511

Brief Summary

The main aim of the study is to examine whether the effects of intranasal oxytocin on eye-gaze behavior towards social stimuli are modulated via individual differences in trait autism

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
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

June 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

September 20, 2017

Last Update Submit

October 26, 2018

Conditions

Keywords

OxytocinEye trackingAutistic trait

Outcome Measures

Primary Outcomes (2)

  • Global eye gaze characteristic: differences between oxytocin and placebo treatment

    Global eye-gaze patterns will be compared between the administration of oxytocin and placebo

    45-90 minutes after treatment administration

  • Feature-specific eye gaze characteristics: differences between oxytocin and placebo treatment

    Localized feature-specific eye gaze patterns will be compared between oxytocin and placebo treatment

    45-90 minutes after treatment administration

Secondary Outcomes (2)

  • Global eye gaze characteristic - associations with autism traits

    45-90 minutes after treatment administration

  • Feature-specific eye gaze characteristics - associations with trait autism

    45-90 minutes after treatment administration

Study Arms (2)

Order of administration: oxytocin - placebo

EXPERIMENTAL

Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo nasal spray

Drug: intranasal oxytocinDrug: intranasal placebo

Order of administration: placebo - oxytocin

EXPERIMENTAL

Participants first received placebo nasal spray. After a washout period of 2 weeks, they then receive oxytocin (24 IU).

Drug: intranasal oxytocinDrug: intranasal placebo

Interventions

24 IU of oxytocin nasal spray will be applied to each subject.

Order of administration: oxytocin - placeboOrder of administration: placebo - oxytocin

24 IU of of placebo nasal spray will be applied to each subject.

Order of administration: oxytocin - placeboOrder of administration: placebo - oxytocin

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects without any past or present psychiatric or neurological disorders

You may not qualify if:

  • History of brain injury
  • Visual impairments
  • Use of medication
  • Contraindications for oxytocin administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Chengdu, Sichuan, 610054, China

RECRUITING

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

Related Publications (1)

  • Le J, Kou J, Zhao W, Fu M, Zhang Y, Becker B, Kendrick KM. Oxytocin Facilitation of Emotional Empathy Is Associated With Increased Eye Gaze Toward the Faces of Individuals in Emotional Contexts. Front Neurosci. 2020 Aug 11;14:803. doi: 10.3389/fnins.2020.00803. eCollection 2020.

Study Officials

  • Juan Kou, MSc

    University of Electronic Science and Technology of China

    STUDY CHAIR

Central Study Contacts

Keith M Kendrick, PhD

CONTACT

Benjamin Becker, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 26, 2017

Study Start

June 9, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations