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Common and Differentiated Representations Between Social Exclusion and Social Separation

Plain-language guide to NCT05920707: not phased randomized trial of Oxytocin and Vasopressin, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05920707
Phase
not phased
Status
status unknown
Start
2023-04-20
Completion (planned or actual)
2023-09-20
Participants
120 (estimated)
Design
randomized, triple-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin and Vasopressin.

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.

It had four arms (groups): Intranasal Oxytocin (active comparator), Intranasal Arginine Vasopressin (active comparator), Intranasal placebo (placebo comparator) and Intranasal nothing (control) (no intervention).

Administer placebo intranasally.

The registry classes the interventions as drug.

More on the Plan

In addition, there are two mainstream theoretical explanations for these differences, namely the construction-level theory and the emotion-based theory, but there is no consistent theoretical model yet.

Therefore, further exploration is necessary to confirm the cognitive and neural mechanisms underlying the differences between social exclusion and social segregation, and to attempt to reveal the theoretical explanations for these differences.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Without any past or present psychiatric or neurological disorders;. Without any current psychotherapeutic medication.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: with any past or present psychiatric or neurological disorders;; with any current psychotherapeutic medication.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-04-20 with completion listed for 2023-09-20.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Neural index: OXT and AVP effects on fMRI based- social exclusion and social separation tasks (time frame: 45 minutes after treatment administration). Behavioral index: behavioral ratings of social exclusion and social separation tasks (time frame: Immediately after fMRI scanning).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Vasopressin in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page and the Vasopressin compound page, all human trials.

Our Notes on the Compounds

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.