HealthyNCT03426176
The Interaction Between Oxytocin and Serotonin
A study testing oxytocin nasal spray and ATD treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus… 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 nasal spray and ATD treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 15 Jul 2019
- 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
- health subjects without past or current psychiatric or neurological disorders
- Right-handedness
Who cannot join
- History of head injury;
- Medical or psychiatric illness.
- High blood pressure, general cardio-vascular alterations
- History of drug or alcohol abuse or addiction.
- Allergy against medications or general strong allergies
- Sleep disorders.
- Visual or motor impairments
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology
Chengdu, Sichuan, 611731
Weihua Zhao, zarazhao.uestc@outlook.com
About this study
Official title: The Interaction Between Oxytocin and Serotonin on the Social-emotional Brain Networks
the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)
Read the detailed description
Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.
- Conditions
- Healthy
- Being tested
- oxytocin nasal spray, intranasal placebo treatment (placebo-control for oxytocin), ATD treatment, oral placebo treatment (placebo-control for ATD)
- Keywords
- oxytocin, acute tryptophan depletion, emotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin nasal sprayDrug
intranasal administration of oxytocin (24 IU)
intranasal placebo treatment (placebo-control for oxytocin)Drug
intranasal administration of placebo nasal spray
ATD treatmentDrug
oral administration of ATD (75.2g) (Acute Tryptophan Depletion)
oral placebo treatment (placebo-control for ATD)Drug
oral administration of a tryptophan-balanced mixture (78.2g)
| Study group | Role | What they receive |
|---|---|---|
| male oxytocin and ATD group | Experimental | male subjects receiving oxytocin and ATD treatment Receives: Drug: oxytocin nasal spray; Drug: ATD treatment |
| male oxytocin and placebo group | Experimental | male subjects receiving oxytocin and ATD-placebo treatment Receives: Drug: oxytocin nasal spray; Drug: oral placebo treatment (placebo-control for ATD) |
| male placebo and ATD group | Experimental | male subjects receiving oxytocin placebo and ATD treatment Receives: Drug: intranasal placebo treatment (placebo-control for oxytocin); Drug: ATD treatment |
| male placebo group | Placebo comparator | male subjects receiving oxytocin placebo and ATD placebo treatment Receives: Drug: intranasal placebo treatment (placebo-control for oxytocin); Drug: oral placebo treatment (placebo-control for ATD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural processing during the emotion processing as assessed via fMRI
fMRI BOLD indices of neural processing in emotion related brain regions will be compared between the treatment groups
Measured: 6h after treatment
Neural processing during the resting state as assessed via fMRI
Resting state activity in the emotional brain networks will be compared between the treatment groups
Measured: 6h after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Feb 2018
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Jul 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426176
- Sponsor's protocol ID
- UESTC-neuSCAN-29
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 8 Feb 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 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between Oxytocin and Serotonin on the Social-emotional Brain Networks
- ClinicalTrials.gov ID
- NCT03426176
- Acronym / sponsor ID
- UESTC-neuSCAN-29
- Conditions
- Healthy
- Keywords
- oxytocin, acute tryptophan depletion, emotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 8 Feb 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.
the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)
Detailed description
Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| male oxytocin and ATD group | Experimental | Drug: oxytocin nasal spray, Drug: ATD treatmentmale subjects receiving oxytocin and ATD treatment |
| male oxytocin and placebo group | Experimental | Drug: oxytocin nasal spray, Drug: oral placebo treatment (placebo-control for ATD)male subjects receiving oxytocin and ATD-placebo treatment |
| male placebo and ATD group | Experimental | Drug: intranasal placebo treatment (placebo-control for oxytocin), Drug: ATD treatmentmale subjects receiving oxytocin placebo and ATD treatment |
| male placebo group | Placebo comparator | Drug: intranasal placebo treatment (placebo-control for oxytocin), Drug: oral placebo treatment (placebo-control for ATD)male subjects receiving oxytocin placebo and ATD placebo treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- health subjects without past or current psychiatric or neurological disorders
- Right-handedness
Key exclusion criteria (7 listed)
- History of head injury;
- Medical or psychiatric illness.
- High blood pressure, general cardio-vascular alterations
- History of drug or alcohol abuse or addiction.
- Allergy against medications or general strong allergies
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 nasal sprayintranasal administration of oxytocin (24 IU) | Drug | male oxytocin and ATD group, male oxytocin and placebo group |
| intranasal placebo treatment (placebo-control for oxytocin)intranasal administration of placebo nasal spray | Drug | male placebo and ATD group, male placebo group |
| ATD treatmentoral administration of ATD (75.2g) (Acute Tryptophan Depletion) | Drug | male oxytocin and ATD group, male placebo and ATD group |
| oral placebo treatment (placebo-control for ATD)oral administration of a tryptophan-balanced mixture (78.2g) | Drug | male oxytocin and placebo group, male placebo group |
Primary outcome
Neural processing during the emotion processing as assessed via fMRI
Time frame: 6h after treatment
fMRI BOLD indices of neural processing in emotion related brain regions will be compared between the treatment groups
Neural processing during the resting state as assessed via fMRI
Time frame: 6h after treatment
Resting state activity in the emotional brain networks will be compared between the treatment groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
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 nasal spray and ATD 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 7 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 8 Feb 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. (86-28-61830988, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural processing during the emotion processing as assessed via fMRI (time frame: 6h 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 8 Feb 2018.