- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815395
Differential Effects of Oral and Intranasal Oxytocin on Attention Control
March 22, 2021 updated by: Keith Kendrick, University of Electronic Science and Technology of China
The Differential Effects of Oral and Intranasal Oxytocin on Attention Control
The main aim of the present study is to investigate whether oxytocin (24IU) via different routes have divergent effects on attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous studies have demonstrated oral and intranasal oxytocin's divergent effects on arousal rating and neural responses to emotional faces, however, it remains unclear whether different routes of oxytocin treatment would have differential effects on attention processing to social stimuli.
Based on the previous registered studies (ClinicalTrials.gov
ID: NCT04493515 and NCT03486925) from our group using a validated emotional anti-saccade task with social stimuli (emotional faces) and non-social stimuli (oval shape) have separately explored oral and intranasal oxytocin's modulatory effects on attention processing, the present study aims to conduct a secondary analysis of the previously acquired data to directly compare oxytocin's effects on attention control to social emotional stimuli via different routes.
To this end data from subjects who underwent intranasal oxytocin administration (n = 33, NCT03486925) will be compared with data from subjects who underwent oral oxytocin or placebo administration (n = 36, or 37 respectively; NCT04493515).
To further control for non-treatment related factors the intranasal placebo and oral placebo groups from the previous studies (ClinicalTrials.gov
ID: NCT03486925 and NCT04493515) will be compared with respect to primary and secondary outcome measures of the trial, in particular general and emotion-specific effects on attentional control.
Study Type
Interventional
Enrollment (Actual)
151
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(UESTC)
-
-
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 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male, healthy participants
- Non smokers
Exclusion Criteria:
- Previous or current medical, psychiatric, neurological disorder
- Regular medication
- Use of any psychoactive substances in the 24 hours before experiment
- Contra-indications for eye-tracking data acquisition
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oral Oxytocin
Oxytocin (24IU) orally
|
Administration of oxytocin (24IU) orally
Administration of oxytocin (24IU) intranasally
|
|
Experimental: Intranasal Oxytocin
Oxytocin (24IU) intranasally
|
Administration of oxytocin (24IU) orally
Administration of oxytocin (24IU) intranasally
|
|
Placebo Comparator: Oral Placebo
Placebo orally
|
Administration of placebo orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differential effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli
Time Frame: 45 minutes - 100 minutes after treatment
|
Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions
|
45 minutes - 100 minutes after treatment
|
|
Differential effects of intranasal and oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli
Time Frame: 45 minutes - 100 minutes after treatment
|
Comparison between social-specific error rates of saccade/antisaccade between the intranasal and oral oxytocin and placebo treatment conditions.
|
45 minutes - 100 minutes after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions
Time Frame: 45 minutes - 100 minutes after treatment
|
Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions
|
45 minutes - 100 minutes after treatment
|
|
Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions
Time Frame: 45 minutes - 100 minutes after treatment
|
Comparison between emotion-specific saccade/antisaccade error rates between the intranasal and oral oxytocin and placebo treatment conditions
|
45 minutes - 100 minutes after 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 (UESTC)
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)
December 19, 2017
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
January 1, 2021
Study Registration Dates
First Submitted
March 22, 2021
First Submitted That Met QC Criteria
March 22, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2021
Last Update Submitted That Met QC Criteria
March 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-80
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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