NCT06405737

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin modulates advantageous- and disadvantageous-inequity and whether oxytocin has similar effects on them or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

May 5, 2024

Last Update Submit

August 12, 2024

Conditions

Keywords

advantageous inequitydisadvantageous inequityfMRIoxytocin

Outcome Measures

Primary Outcomes (3)

  • Behavioral index: fairness rating scores

    Participants are instructed to rate their perceived levels of fairness to the allocation using a 9-point Likert scale within 4 seconds (1 = very unfair, 9 = very fair).

    45-75 minutes after treatment administration

  • Behavioral index: preference rating scores

    Participants are instructed to rate their perceived levels of preference to the allocation using a 9-point Likert scale within 4 seconds (1 = not at all, 9 = very preferable).

    45-75 minutes after treatment administration

  • Neural indices: fMRI-based measures of the outcome presentation stage

    Functional magnetic resonance imaging (fMRI) is employed to assess participants' blood-oxygen-level dependent signals when they are confronted with monetary allocations (advantageous-inequity, disadvantageous-inequity, and fair).

    45-75 minutes after treatment administration

Secondary Outcomes (2)

  • Behavioral index: choice rate of unequal option

    45-75 minutes after treatment administration

  • Neural indices: fMRI-based measures of outcome and re-decision stages

    45-75 minutes after treatment administration

Study Arms (2)

oxytocin

EXPERIMENTAL

a single dose of 24 international units (IU) of OT will be administered with 3 puffs of treatment to each nostril.

Drug: Intranasal oxytocin

placebo

EXPERIMENTAL

a single dose of 24 international units (IU) of placebo will be administered with 3 puffs of treatment to each nostril.

Drug: Intranasal placebo

Interventions

Subject assigned to receive intranasal administration of oxytocin (24 IU).

oxytocin

Subjects assigned to receive intranasal administration of placebo (24 IU).

placebo

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
  • pregnant,menstruating,taking oral contraceptives
  • medical or psychiatric illness.
  • excessive head movement (\> 3mm) during scanning

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

Location

Study Officials

  • Yao Shuxia, Dr

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

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

May 5, 2024

First Posted

May 8, 2024

Study Start

January 7, 2024

Primary Completion

June 12, 2024

Study Completion

June 20, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations