HealthyNCT04493515
Oral Oxytocin's Effects on Attention Control
A study testing Oral Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral Oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, healthy participants
- Non smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
Zhao Weihua, PhD, +86 2861 830 811, zarazhao.uestc@outlook.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Oral Oxytocin, Oral Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral OxytocinDrug
Administration of oxytocin orally (24 IU)
Oral PlaceboDrug
Administration of placebo orally (24 IU)
| Study group | Role | What they receive |
|---|---|---|
| Oral Oxytocin | Experimental | Oxytocin orally (24 IU) Receives: Drug: Oral Oxytocin |
| Oral Placebo | Placebo comparator | Placebo orally (24 IU, identical ingredients, except the active agent) Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli
Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
Measured: 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
Comparison between social-specific error rates of saccade/antisaccade between the oxytocin and placebo treatment conditions.
Measured: 45 minutes - 100 minutes after treatment
Secondary outcomes (2)
Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions
Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
Measured: 45 minutes - 100 minutes after treatment
Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions
Comparison between emotion-specific saccade/antisaccade error rates between the oxytocin and placebo treatment conditions
Measured: 45 minutes - 100 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start28 Jul 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, PhD, Principal investigator, University of Electronic Science and Technology of China (UESTC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493515
- Sponsor's protocol ID
- UESTC-neuSCAN-69
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Oxytocin's Effects on Attention Control: An Eye-tracking Study
- ClinicalTrials.gov ID
- NCT04493515
- Acronym / sponsor ID
- UESTC-neuSCAN-69
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
| Arm | Type | Receives |
|---|---|---|
| Oral Oxytocin | Experimental | Drug: Oral OxytocinOxytocin orally (24 IU) |
| Oral Placebo | Placebo comparator | Drug: Oral PlaceboPlacebo orally (24 IU, identical ingredients, except the active agent) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male, healthy participants
- Non smokers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral OxytocinAdministration of oxytocin orally (24 IU) | Drug | Oral Oxytocin |
| Oral PlaceboAdministration of placebo orally (24 IU) | Drug | Oral Placebo |
Primary outcome
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
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.
2 secondary outcomes
Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Kendrick, PhD principal investigator
University of Electronic Science and Technology of China (UESTC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuang Qian, MD (13086663679, zq19910362@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.