NCT02682888

Brief Summary

to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it

Trial Health

87
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 2015

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

December 8, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

5.7 years

First QC Date

February 8, 2016

Last Update Submit

February 10, 2022

Conditions

Keywords

brain functional connectivity changes

Outcome Measures

Primary Outcomes (1)

  • the resting state functional connectivity changes in the defensive network

    The resting-state activity can be accessed using functional magnetic resonance imaging (fMRI) by measuring spontaneous and low-frequency fluctuations (\< 0.1 Hz) when the brain is at rest. Group differences will be calculated in the high trait anxiety group relative to the low trait anxiety group and in the oxytocin group relative to the placebo group.

    one day

Study Arms (4)

high trait anxiety group

EXPERIMENTAL

experiment 1: identified according to scores of the trait anxiety scale.

Behavioral: trait anxiety scale

low trait anxiety group

EXPERIMENTAL

experiment 1: identified according to scores of the trait anxiety scale.

Behavioral: trait anxiety scale

oxytocin group

EXPERIMENTAL

experiment 2: intranasal administration of oxytocin

Drug: Oxytocin

placebo control group

PLACEBO COMPARATOR

experiment 2: intranasal administration of placebo

Drug: Placebo

Interventions

splitting subjects into 2 groups according to scores of the trait anxiety scale

high trait anxiety grouplow trait anxiety group

intranasal administration of oxytocin

oxytocin group

intranasal administration of placebo

placebo control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
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:

  • females should not be pregnant or during menstruation.

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, 610054, China

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Keith Kendrick, 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
Prof.

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 17, 2016

Study Start

December 8, 2015

Primary Completion

August 19, 2021

Study Completion

November 20, 2021

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations