HealthyNCT03128242
Oxytocin's Effect on Attention Training
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
This study aims to investigate oxytocin's effect on attentional bias training. Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral). Effects of the training will be assessed using an eye-tracking anti-saccade task. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2016to 30 Dec 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 participants with elevated trait anxiety (> 45 scores as assessed with the State and Trait Anxiety Inventory, Spielberger, 1983)
- without past or current psychiatric or neurological disorders
Who cannot join
- history of head injury
- medical or psychiatric illness
- smoking or drinking 24 hours before the experiment
Trial locations and contacts
1 site in 1 country.
Benjamin Becker, Dr. contact
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Benjamin Becker, Dr., ben_becker@gmx.de
About this study
Official title: An Eye-tracking Study to Investigate Oxytocin's Effect on Attentional Bias Training
This study aims to investigate oxytocin's effect on attentional bias training. Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral). Effects of the training will be assessed using an eye-tracking anti-saccade task.
Read the detailed description
In this study, a dot-probe task will be used to examine if subjects show an attentional bias towards negative stimuli and whether the bias can be modified using a subsequent attentional bias training. During this training participants learn to direct their attention away from threatening stimuli. In a between-subject placebo controlled design participants will receive either intranasal oxytocin or placebo before the training to examine whether oxytocin could facilitate the effects of the attention training. Effects of the training and of oxytocin on the training will be assessed by means of an eye-tracking anti-saccade task. Based on previous studies showing the strongest effects of threat-attentional bias training in high anxious subjects, the study will recruit participants with an elevated trait anxiety.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
intranasal administration of oxytocin (24IU)
placeboDrug
intranasal administration of placebo (24IU)
| Study group | Role | What they receive |
|---|---|---|
| oxytocin group | Experimental | oxytocin treatment Receives: Drug: Oxytocin |
| placebo group | Placebo comparator | placebo treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (RT) difference - oxytocin effects
Difference before and after oxytocin administration: reaction time to negative and neutral stimuli in the dot-probe task
Measured: Before drug administration (pre-treatment baseline) and 55 minutes after drug administration
Reaction time (RT) difference - training effects
Difference before and after training: reaction time to negative and neutral stimuli in the dot-probe task
Measured: Before drug administration - 55-90 minutes after drug administration
Saccade latency difference - training effects
Difference before and after training in saccade latency in the anti-saccade task
Measured: Before drug administration - 55-90 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start25 Nov 2016
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Benjamin Becker, Dr., Principal investigator, School of Life Science and Technology, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128242
- Sponsor's protocol ID
- UESTC-neuSCAN-32
- Status last verified
- Oct 2018
- First submitted
- 17 Apr 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eye-tracking Study to Investigate Oxytocin's Effect on Attentional Bias Training
- ClinicalTrials.gov ID
- NCT03128242
- Acronym / sponsor ID
- UESTC-neuSCAN-32
- Conditions
- Healthy
- Keywords
- oxytocin, attention bias, attention training, eye-tracking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 25 Apr 2017 (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.
This study aims to investigate oxytocin's effect on attentional bias training. Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral). Effects of the training will be assessed using an eye-tracking anti-saccade task.
Detailed description
In this study, a dot-probe task will be used to examine if subjects show an attentional bias towards negative stimuli and whether the bias can be modified using a subsequent attentional bias training. During this training participants learn to direct their attention away from threatening stimuli. In a between-subject placebo controlled design participants will receive either intranasal oxytocin or placebo before the training to examine whether oxytocin could facilitate the effects of the attention training. Effects of the training and of oxytocin on the training will be assessed by means of an eye-tracking anti-saccade task. Based on previous studies showing the strongest effects of threat-attentional bias training in high anxious subjects, the study will recruit participants with an elevated trait anxiety.
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: Oxytocinoxytocin treatment |
| placebo group | Placebo comparator | Drug: placeboplacebo treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male participants with elevated trait anxiety (> 45 scores as assessed with the State and Trait Anxiety Inventory, Spielberger, 1983)
- without past or current psychiatric or neurological disorders
Key exclusion criteria (3 listed)
- history of head injury
- medical or psychiatric illness
- smoking or drinking 24 hours before the experiment
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 |
|---|---|---|
| Oxytocinintranasal administration of oxytocin (24IU) | Drug | oxytocin group |
| placebointranasal administration of placebo (24IU) | Drug | placebo group |
Primary outcome
Reaction time (RT) difference - oxytocin effects
Time frame: Before drug administration (pre-treatment baseline) and 55 minutes after drug administration
Difference before and after oxytocin administration: reaction time to negative and neutral stimuli in the dot-probe task
Reaction time (RT) difference - training effects
Time frame: Before drug administration - 55-90 minutes after drug administration
Difference before and after training: reaction time to negative and neutral stimuli in the dot-probe task
Saccade latency difference - training effects
Time frame: Before drug administration - 55-90 minutes after drug administration
Difference before and after training in saccade latency in the anti-saccade task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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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.
Benjamin Becker, Dr. contact
Benjamin Becker, Dr. principal investigator
School of Life Science and Technology, University of Electronic Science and Technology of China
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 3 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 29 Oct 2018. 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 Benjamin Becker, Dr. (ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (RT) difference - oxytocin effects (time frame: Before drug administration (pre-treatment baseline) and 55 minutes after drug administration). The study lists 3 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 29 Oct 2018.