HealthyNCT04815395
Differential Effects of Oral and Intranasal Oxytocin on Attention Control
A study testing 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 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. 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?
- Oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2017to 1 Jan 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 eye-tracking data acquisition
Trial locations and contacts
1 site in 1 country.
China1 site
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Administration of oxytocin (24IU) orally
OxytocinDrug
Administration of oxytocin (24IU) intranasally
PlaceboDrug
Administration of placebo orally
| Study group | Role | What they receive |
|---|---|---|
| Oral Oxytocin | Experimental | Oxytocin (24IU) orally Receives: Drug: Oxytocin |
| Intranasal Oxytocin | Experimental | Oxytocin (24IU) intranasally Receives: Drug: Oxytocin |
| Oral Placebo | Placebo comparator | Placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential effects of intranasal and 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 intranasal and oral oxytocin and placebo treatment conditions
Measured: 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
Comparison between social-specific error rates of saccade/antisaccade between the intranasal and oral oxytocin and placebo treatment conditions.
Measured: 45 minutes - 100 minutes after treatment
Secondary outcomes (2)
Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions
Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions
Measured: 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
Comparison between emotion-specific saccade/antisaccade error rates between the intranasal and oral 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 posted25 Mar 2021
- Study start19 Dec 2017
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
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
- 151 participants (actual)
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
- NCT04815395
- Sponsor's protocol ID
- UESTC-neuSCAN-80
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 25 Mar 2021
- 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 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Effects of Oral and Intranasal Oxytocin on Attention Control
- ClinicalTrials.gov ID
- NCT04815395
- Acronym / sponsor ID
- UESTC-neuSCAN-80
- Conditions
- Healthy
- Keywords
- Antisaccade task, Attention control, Oxytocin, Eye-tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 25 Mar 2021 (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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
| Arm | Type | Receives |
|---|---|---|
| Oral Oxytocin | Experimental | Drug: OxytocinOxytocin (24IU) orally |
| Intranasal Oxytocin | Experimental | Drug: OxytocinOxytocin (24IU) intranasally |
| Oral Placebo | Placebo comparator | Drug: PlaceboPlacebo orally |
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 (4 listed)
- 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
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 |
|---|---|---|
| OxytocinAdministration of oxytocin (24IU) orally | Drug | Oral Oxytocin |
| OxytocinAdministration of oxytocin (24IU) intranasally | Drug | Intranasal Oxytocin |
| PlaceboAdministration of placebo orally | Drug | Oral Placebo |
Primary outcome
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
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- 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 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 4 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: finished, as of the sponsor's last update on 25 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 25 Mar 2021.