- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04493515
Oral Oxytocin's Effects on Attention Control
July 27, 2020 updated by: Keith Kendrick, University of Electronic Science and Technology of China
Oral Oxytocin's Effects on Attention Control: An Eye-tracking Study
The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate attention control using a social-emotional saccade/antisaccade eye-tracking paradigm.
Study Overview
Detailed Description
Numerous studies have reported the effect of intranasally administered oxytocin on attentional processing including stimulus-driven bottom-up processing and top-down goal-directed inhibitory control.
However, it is unclear whether the functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations.
One possible method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually.
In the present double-blind, between-subject, placebo-controlled study, 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual).
45 minutes after treatment subjects are required to complete a social-emotional saccade/antisaccade eye-tracking paradigm.
This paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore social- and emotion-specific effects of orally administered oxytocin.
Study Type
Interventional
Enrollment (Anticipated)
80
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
- Recruiting
- University of Electronic Science and Technology of China(UESTC)
-
Contact:
- Zhao Weihua, PhD
- Phone Number: +86 2861 830 811
- Email: zarazhao.uestc@outlook.com
-
-
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
14 years to 26 years (Adult)
Accepts Healthy Volunteers
No
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 oxytocin
- 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 orally (24 IU)
|
Administration of oxytocin orally (24 IU)
|
|
Placebo Comparator: Oral Placebo
Placebo orally (24 IU, identical ingredients, except the active agent)
|
Administration of placebo orally (24 IU)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of 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 oxytocin and placebo treatment conditions
|
45 minutes - 100 minutes after treatment
|
|
Effect of 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 oxytocin and placebo treatment conditions.
|
45 minutes - 100 minutes after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion-specific effects of 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 oxytocin and placebo treatment conditions
|
45 minutes - 100 minutes after treatment
|
|
Emotion-specific effects of 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 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)
July 28, 2020
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
July 27, 2020
First Submitted That Met QC Criteria
July 27, 2020
First Posted (Actual)
July 30, 2020
Study Record Updates
Last Update Posted (Actual)
July 30, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-69
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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