HealthyEarly Phase 1NCT03055546
Effects of Intranasal Oxytocin on Emotion Regulation
A Early Phase 1 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 aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms. 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Mar 2019
- Phase
- Early Phase 1
- 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
- healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Weihua Zhao, Master contact
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology, University of Electronic Science and Technology
Chengdu, Sichuan, 611731
Zhao Weihua, zarazhao.uestc@outlook.com
About this study
The aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms.
Read the detailed description
In the present study, the investigators plan to conduct a between-subject, double-blind, placebo-controlled experiment to investigate the effects of oxytocin on neural, physiological and behavior activity related to emotion regulation. The emotion regulation ability will be assessed by emotional go-nogo task and cognitive reappraisal task. The neural activity will be explored by functional magnetic resonance imaging (fMRI). And the investigators will record participants' heart rate during fMRI to investigate the effects of oxytocin on heart rate variability in emotion regulation process.
All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety before self-administration, including Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and Buss shyness Scale (CBSS), Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ), Interpersonal Reactivity Index (IRI), Action Control Scale (ACS), Emotion Regulation Questionnaire (ERQ), Berkley Expressivity Questionnaire (BEQ), and so on.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
intranasal administration of oxytocin
PlaceboDrug
Also called Intranasal Placebo
intranasal administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | intranasal administration of oxytocin Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | intranasal administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin effects on neural activity during emotion regulation task
Neural activity will be measured by functional magnetic resonance imaging (fMRI). Differences in activity of prefrontal cortex (PFC) and amygdala will be compared between oxytocin and placebo groups during emotional go-nogo task and cognitive reappraisal task.
Measured: Between 45-110 minutes after the intranasal administration of oxytocin
Secondary outcomes (4)
Oxytocin effects on heart rate variability during emotion regulation task
The heart rate will be recorded during the fMRI. The effects of oxytocin will be assessed by determining changes in heart rate variability between oxytocin and placebo groups during emotional go-nogo task and cognitive reappraisal task.
Measured: Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on behavior response during emotion regulation task
The effects of oxytocin will be assessed by determining changes in reaction time and accuracy during emotional go-nogo task and negative affect ratings during cognitive reappraisal task between oxytocin and placebo groups.
Measured: Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on heart rate variability during resting-state
The heart rate will be recorded during the resting-state. The effects of oxytocin will be assessed by determining changes in heart rate variability between oxytocin and placebo groups during resting-state.
Measured: Between 35-45 minutes after the intranasal administration of oxytocin
Oxytocin effects on neural activity during resting-state
The effects of oxytocin will be assessed by determining changes in neural activity between oxytocin and placebo groups during resting-state.
Measured: Between 35-45 minutes after the intranasal administration of oxytocin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, Dr., Study director, University of Electronic Science and Technology of ChinaBenjamin Becker, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055546
- Sponsor's protocol ID
- UESTC-neuSCAN-11
- Status last verified
- Oct 2018
- First submitted
- 15 Apr 2016
- Last updated
- 29 Oct 2018
- 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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Oxytocin on Emotion Regulation
- ClinicalTrials.gov ID
- NCT03055546
- Acronym / sponsor ID
- UESTC-neuSCAN-11
- Conditions
- Healthy
- Keywords
- oxytocin, emotion regulation
- Phase
- Early Phase 1
- 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
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 16 Feb 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.
The aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms.
Detailed description
In the present study, the investigators plan to conduct a between-subject, double-blind, placebo-controlled experiment to investigate the effects of oxytocin on neural, physiological and behavior activity related to emotion regulation. The emotion regulation ability will be assessed by emotional go-nogo task and cognitive reappraisal task. The neural activity will be explored by functional magnetic resonance imaging (fMRI). And the investigators will record participants' heart rate during fMRI to investigate the effects of oxytocin on heart rate variability in emotion regulation process.
All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety before self-administration, including Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and Buss shyness Scale (CBSS), Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ), Interpersonal Reactivity Index (IRI), Action Control Scale (ACS), Emotion Regulation Questionnaire (ERQ), Berkley Expressivity Questionnaire (BEQ), and so on.
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 | Experimental | Drug: Oxytocinintranasal administration of oxytocin |
| Placebo | Placebo comparator | Drug: Placebointranasal administration of placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (3 listed)
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
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 |
|---|---|---|
| OxytocinAlso: Syntocinonintranasal administration of oxytocin | Drug | Oxytocin |
| PlaceboAlso: Intranasal Placebointranasal administration of placebo | Drug | Placebo |
Primary outcome
Oxytocin effects on neural activity during emotion regulation task
Time frame: Between 45-110 minutes after the intranasal administration of oxytocin
Neural activity will be measured by functional magnetic resonance imaging (fMRI). Differences in activity of prefrontal cortex (PFC) and amygdala will be compared between oxytocin and placebo groups during emotional go-nogo task and cognitive reappraisal task.
4 secondary outcomes
Oxytocin effects on heart rate variability during emotion regulation task
Time frame: Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on behavior response during emotion regulation task
Time frame: Between 45-110 minutes after the intranasal administration of oxytocin
Oxytocin effects on heart rate variability during resting-state
Time frame: Between 35-45 minutes after the intranasal administration of oxytocin
Oxytocin effects on neural activity during resting-state
Time frame: Between 35-45 minutes after the intranasal administration of oxytocin
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.
- 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.
Weihua Zhao, Master contact
Keith Kendrick, Dr. study director
University of Electronic Science and Technology of China
Benjamin Becker principal investigator
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 Early Phase 1 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 1 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weihua Zhao, Master (zarazhao.uestc@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin effects on neural activity during emotion regulation task (time frame: Between 45-110 minutes after the intranasal administration of oxytocin). 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.