NCT03597893

Brief Summary

To investigate the effect of 24IU intranasal oxytocin on belief updating when people in stress or non-stress condition.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable healthy

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

December 27, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

July 2, 2018

Last Update Submit

July 22, 2018

Conditions

Keywords

intranasal oxytocinstressbelief updating

Outcome Measures

Primary Outcomes (3)

  • The updated probability estimation for negative events in the four experimental groups

    Using the second estimation value to minus the first estimation value to get the update value, as well as calculating the update value in desirable condition (first estimation \< feedback) and undesirable condition (first estimation \< feedback). Then investigated the general belief updating (gBU) and optimistic belief updating (using desirableBU-undesirableBU) in the four experimental condition (i.e., oxytocin-stress, oxytocin-nonstress, placebo-stress, placebo-nonstress).

    40~125 minutes after drug administration

  • The salivary cortisol level in four experimental groups

    Conducted ANOVA to test salivary cortisol level in the four experimental groups

    40~125 minutes after drug administration

  • The correlation between personality traits and belief updating value in four experimental groups

    Conducted correlation analysis to explore which personality traits would modulate the oxytocin effect or stress effect.

    40~125 minutes after drug administration

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (24 IU or 40.32 mg; Syntocinon-spray; Novartis, Switzerland) .

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo contains all ingredients except for the peptide in three puffs of 3.99 IU per 6.72mg nostril.

Drug: Placebo

Interventions

intranasally administrated

Oxytocin

intranasally administrated

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailswe opted to recruit only males for the present study.
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:

  • subjects with past or current psychiatric or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

OxytocinSodium Chloride

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The study utilized a randomized, double-blind, PBO controlled, between-subject design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 24, 2018

Study Start

December 27, 2016

Primary Completion

August 15, 2017

Study Completion

June 30, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07