NCT04413786

Brief Summary

To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on attentional processing of emotional faces.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2021

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

May 25, 2020

Last Update Submit

February 8, 2022

Conditions

Healthy

Keywords

oxytocinemotional facesattentionN2pc

Outcome Measures

Primary Outcomes (2)

  • Response time in reponse to different emotional face targets.

    Response time in discriminating which side (left or right) the emotional face target appear.

    1 hour

  • N2pc

    N2pc is an enhanced negative event-related potential typically elicited at posterior electrodes (e.g., PO7 and PO8) contralateral to the target presented among distractors between 180 and 300 ms after the onset of stimuli. display.

    1 hour

Secondary Outcomes (1)

  • Response accuracy in response to different emotional face targets.

    1 hour

Study Arms (2)

oxytocin group

EXPERIMENTAL

male subjects with oxytocin treatment

Drug: oxytocin treatment

placebo group

PLACEBO COMPARATOR

male subjects with placebo treatment

Drug: placebo treatment

Interventions

oxytocin treatmentDRUG

intranasal administration of oxytocin (24IU)

oxytocin group
placebo treatmentDRUG

intranasal administration of placebo (24IU)

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
  • medical or psychiatric illness

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

Study Officials

  • Shuxia Yao, Doctor

    University of Electronic Science and Technology

    STUDY DIRECTOR

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
Associate Professor

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 4, 2020

Study Start

October 14, 2019

Primary Completion

December 16, 2021

Study Completion

December 26, 2021

Last Updated

February 9, 2022

Record last verified: 2022-02

Locations

CN(1)