NCT02741063

Brief Summary

to investigate whether oxytocin alter attentional bias towards emotional expression faces in individuals with high and low autistic traits, and the brain mechanism of this effect

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
120

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started May 2016

Longer than P75 for early_phase_1 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

March 30, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

3.1 years

First QC Date

March 30, 2016

Last Update Submit

October 26, 2018

Conditions

Healthy

Keywords

oxytocinattentional biasAutism

Outcome Measures

Primary Outcomes (1)

  • attentional bias toward emotional expression faces

    attentional bias was measured by the accuracy of each emotional faces in the RSVP task

    1 hour

Secondary Outcomes (1)

  • brain activity during RSVP task

    1 hour

Study Arms (4)

high autistic and oxytocin group

EXPERIMENTAL

subject with high ASQ scores will receive oxytocin treatment

Behavioral: screen high autistic subjectsDrug: oxytocin

low autistic and oxytocin group

EXPERIMENTAL

subject with low ASQ scores will receive oxytocin treatment

Behavioral: screen low autistic subjectsDrug: oxytocin

high autistic and placebo group

PLACEBO COMPARATOR

subject with high ASQ scores will receive placebo treatment

Behavioral: screen high autistic subjectsDrug: placebo

low autistic and placebo group

PLACEBO COMPARATOR

subject with low ASQ scores will receive placebo treatment

Behavioral: screen low autistic subjectsDrug: placebo

Interventions

screen low autistic subjectsBEHAVIORAL

screen subjects with low ASQ score

low autistic and oxytocin grouplow autistic and placebo group
screen high autistic subjectsBEHAVIORAL

screen subjects with high ASQ score

high autistic and oxytocin grouphigh autistic and placebo group
oxytocinDRUG

intranasal administration of oxytocin (24 IU)

high autistic and oxytocin grouplow autistic and oxytocin group
placeboDRUG

intranasal administration of placebo (24 IU)

high autistic and placebo grouplow autistic and placebo group

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:

  • history of head injury;
  • claustrophobia;
  • medical or psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China, Sichuan

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

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

Central Study Contacts

Keith Kendrick, Dr.

CONTACT

k.kendrick.uestc@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 18, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

CN(1)