- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074409
The Modulatory Effect of Oxytocin on Interoception
September 25, 2019 updated by: Keith Kendrick, University of Electronic Science and Technology of China
This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.
Study Overview
Detailed Description
The present study will use a double-blind, between-subject, placebo-controlled design to investigate the modulatory effect of oxytocin on interoception and whether this effect will vary as a function of emotional valence.
In Experiment 1, subjects will perform a heartbeat detection task and the group differences between oxytocin and placebo groups of the interoceptive accuracy and neural activity in the core interoceptive network will be investigated.
In Experiment 2, subjects will be asked to watch emotional faces while perform the heartbeat detection task.
Investigators will examine whether oxytocin's effects on interoception will be varied as a function of different emotional valence.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- University of Electronic Science and Technology of China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: oxytocin
intranasal administration of oxytocin
|
self-administration of oxytocin (nasal spray)
|
|
Placebo Comparator: placebo
intranasal administration of the same ingredient except oxytocin
|
self-administration of placebo (nasal spray)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heartbeat Detection (Interoception) Accuracy
Time Frame: 45 minutes after oxytocin/placebo treatment
|
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
Time Frame: 45 minutes after oxytocin/placebo treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Keith Kendrick, PhD, University of Electronic Science and Technology of China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2017
Primary Completion (Actual)
September 6, 2017
Study Completion (Actual)
September 12, 2017
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Actual)
October 18, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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