NCT03074409

Brief Summary

This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

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

March 2, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 18, 2019

Completed
Last Updated

October 18, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

March 3, 2017

Results QC Date

October 29, 2018

Last Update Submit

September 25, 2019

Conditions

Keywords

Oxytocin

Outcome Measures

Primary Outcomes (2)

  • Heartbeat Detection (Interoception) Accuracy

    heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (\|recorded heartbeats - counted heartbeats\|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task.

    45 minutes after oxytocin/placebo treatment

  • Interoceptive Network Activity

    interoceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process).

    45 minutes after oxytocin/placebo treatment

Study Arms (2)

oxytocin

EXPERIMENTAL

intranasal administration of oxytocin

Drug: oxytocin

placebo

PLACEBO COMPARATOR

intranasal administration of the same ingredient except oxytocin

Drug: placebo

Interventions

self-administration of oxytocin (nasal spray)

oxytocin

self-administration of placebo (nasal spray)

placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Subjects reported having any neurological problems, psychiatric illness or drug or alcohol abuse and none were currently taking any form of medication and had not drunk any caffeine-containing beverages on the day of the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Shuxia Yao
Organization
University of Electronic Science and Technology of China

Study Officials

  • Keith Kendrick, PhD

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

March 3, 2017

First Posted

March 8, 2017

Study Start

March 2, 2017

Primary Completion

September 6, 2017

Study Completion

September 12, 2017

Last Updated

October 18, 2019

Results First Posted

October 18, 2019

Record last verified: 2019-09

Locations