NCT05920707

Brief Summary

Explore the shared or separated neural mechanisms of social exclusion and social segregation and compare differential effects of AVP and OXT on these social interaction function.

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 not_applicable healthy

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 2, 2023

Last Update Submit

June 27, 2023

Conditions

Keywords

Social exclusionSocial separationOxytocinArginine VasopressinfMRI

Outcome Measures

Primary Outcomes (2)

  • Neural index: OXT and AVP effects on fMRI based- social exclusion and social separation tasks

    Comparions between OXT and AVP on social exclusion and social separation on brain activity or representations

    45 minutes after treatment administration

  • Behavioral index: behavioral ratings of social exclusion and social separation tasks

    Comparions between social exclusion and social separation in pain ratings

    Immediately after fMRI scanning

Study Arms (4)

Intranasal Oxytocin

ACTIVE COMPARATOR

Administer oxytocin (24 IU) intranasally.

Drug: Intranasal Oxytocin

Intranasal Arginine Vasopressin

ACTIVE COMPARATOR

Administer Arginine Vasopressin (20 IU) intranasally.

Drug: Intranasal Arginine Vasopressin

Intranasal placebo

PLACEBO COMPARATOR

Administer placebo intranasally.

Drug: Intranasal placebo

Intranasal nothing (control)

NO INTERVENTION

Control condition

Interventions

Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0. 1ml), three puffs per nostril one every 30 seconds.

Intranasal Oxytocin

Administer arginine vasopressin (20 IU) intranasally, 6 individual 0.1 ml puffs (3.33 IU/0. 1ml), three puffs per nostril one every 30 seconds.

Intranasal Arginine Vasopressin

Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds.

Intranasal placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects;
  • Without any past or present psychiatric or neurological disorders;
  • Without any current psychotherapeutic medication.

You may not qualify if:

  • With any past or present psychiatric or neurological disorders;
  • With any current psychotherapeutic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Social IsolationDiabetes Insipidus

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Siying Wang, Dr

    University of Electronic Science and Technology of China

    STUDY CHAIR

Central Study Contacts

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: Randomized placebo-controlled double-blind between-subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 27, 2023

Study Start

April 20, 2023

Primary Completion

September 20, 2023

Study Completion

October 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations