HealthyNCT03486925
Oxytocin Effect on Attention Inhibition
A study testing oxytocin treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
Effects of intranasal oxytocin (24IU) on cognitive control of attention 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 treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2017to 28 Aug 2018
- 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
School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
Official title: An Eye-tracking Study to Investigate Oxytocin Effect on Attention Inhibition
Effects of intranasal oxytocin (24IU) on cognitive control of attention
Read the detailed description
The cognitive control of attention towards neutral and emotional stimuli represents a key functional domain and disruptions in this domain have been associated with a range of psychiatric disorders. Saccadic eye movement tasks have been used to assess individual differences in the cognitive control of attention and alterations in psychiatric disorders. Recent evidence suggests that the hypothalamic neuropeptide Oxytocin (OXT) may modulate attention allocation and regulation. To this end the present randomized between-subject placebo-controlled experiment examined whether intranasal OXT modulates behavior in an eye-tracking saccade / anti-saccade paradigm in healthy male subjects. The paradigm used non-social (neutral shape) as well as social (happy, sad, angry, fear, and neutral faces) stimuli to explore emotion-specific effects of OXT.
- Conditions
- Healthy
- Being tested
- oxytocin treatment, placebo treatment
- Keywords
- oxytocin, eye-tracking, attention inhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin treatmentDrug
intranasal administration of oxytocin (24IU)
placebo treatmentDrug
intranasal administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| oxytocin group | Experimental | Not described Receives: Drug: oxytocin treatment |
| placebo group | Placebo comparator | Not described Receives: Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotion-specific saccade latencies
comparison between emotion-specific saccade latencies between the treatment groups (in milliseconds)
Measured: 45 minutes - 100 minutes after treatment
emotion-specific error rates
comparison between the emotion-specific ratio of unsuccessful anti-saccades between the treatment groups.
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 posted3 Apr 2018
- Study start19 Dec 2017
- Primary completion20 Jul 2018
- Study completion28 Aug 2018
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 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, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486925
- Sponsor's protocol ID
- UESTC-neuSCAN-45
- Status last verified
- Feb 2019
- First submitted
- 27 Mar 2018
- Last updated
- 4 Mar 2019
- Results posted
- 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 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eye-tracking Study to Investigate Oxytocin Effect on Attention Inhibition
- ClinicalTrials.gov ID
- NCT03486925
- Acronym / sponsor ID
- UESTC-neuSCAN-45
- Conditions
- Healthy
- Keywords
- oxytocin, eye-tracking, attention inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 3 Apr 2018 (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.
Effects of intranasal oxytocin (24IU) on cognitive control of attention
Detailed description
The cognitive control of attention towards neutral and emotional stimuli represents a key functional domain and disruptions in this domain have been associated with a range of psychiatric disorders. Saccadic eye movement tasks have been used to assess individual differences in the cognitive control of attention and alterations in psychiatric disorders. Recent evidence suggests that the hypothalamic neuropeptide Oxytocin (OXT) may modulate attention allocation and regulation. To this end the present randomized between-subject placebo-controlled experiment examined whether intranasal OXT modulates behavior in an eye-tracking saccade / anti-saccade paradigm in healthy male subjects. The paradigm used non-social (neutral shape) as well as social (happy, sad, angry, fear, and neutral faces) stimuli to explore emotion-specific effects of OXT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin group | Experimental | Drug: oxytocin treatment |
| placebo group | Placebo comparator | Drug: placebo treatment |
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 |
|---|---|---|
| oxytocin treatmentintranasal administration of oxytocin (24IU) | Drug | oxytocin group |
| placebo treatmentintranasal administration of placebo | Drug | placebo group |
Primary outcome
emotion-specific saccade latencies
Time frame: 45 minutes - 100 minutes after treatment
comparison between emotion-specific saccade latencies between the treatment groups (in milliseconds)
emotion-specific error rates
Time frame: 45 minutes - 100 minutes after treatment
comparison between the emotion-specific ratio of unsuccessful anti-saccades between the treatment groups.
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 4 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 treatment 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: finished, as of the sponsor's last update on 4 Mar 2019. 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?
emotion-specific saccade latencies (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 4 Mar 2019.