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Trial · Interventional

CompletedNot applicableResults postedRegistry data

The Modulatory Effect of Oxytocin on Interoception

NCTNCT03074409 (opens ClinicalTrials.gov in a new tab)Other idUESTC-neuSCAN-34
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
83 participants (actual)
Sponsor
University of Electronic Science and Technology of China · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
2 Mar 2017
Primary completion
6 Sept 2017
Completion
12 Sept 2017
First posted
8 Mar 2017
Last update posted
18 Oct 2019
Conditions
Interoception

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018
  1. N/A

    The Modulatory Effect of Oxytocin on Interoception

    NCT03074409

    2 Mar 2017 to 12 Sept 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • oxytocinDrug
  • placeboDrug

Arms2

  • Experimental

    oxytocin

    intranasal administration of oxytocin

  • Placebo comparator

    placebo

    intranasal administration of the same ingredient except oxytocin

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Heartbeat Detection (Interoception) Accuracy

    Time frame · 45 minutes after oxytocin/placebo treatment

    Registry description

    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.

  2. Interoceptive Network Activity

    Time frame · 45 minutes after oxytocin/placebo treatment

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 45 minutes after oxytocin/placebo treatment

Heartbeat Detection (Interoception) Accuracy

GroupValue (ratio of correct heartbeat counting)Spread
Oxytocin0.6370.035
Placebo0.7350.034
Primary outcomeMean· 45 minutes after oxytocin/placebo treatment

Interoceptive Network Activity

GroupValue (percentage of BOLD signal change)Spread
Oxytocin0.5480.095
Placebo0.0910.092

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocinintranasal administration of oxytocin oxytocin: self-administration of oxytocin (nasal spray)0 / 410 / 410 / 41
Placebointranasal administration of the same ingredient except oxytocin placebo: self-administration of placebo (nasal spray)0 / 420 / 420 / 42

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy subjects Exclusion Criteria: * 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.

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