HealthyNCT03577457
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 primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design 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 20 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
- Healthy 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.
About this study
Official title: The Interaction Between Oxytocin and Serotonin on the Social-reward Brain Networks and Decision Making
The primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design
Read the detailed description
Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human. The aim of this study is to determine whether they interact in those essential human behaviors by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design, in which 4 groups of healthy males will be administered with a random combination of nasal oxytocin (24 international units, IU) or placebo and acute tryptophan depletion (ATD, 75.2g) or placebo (a tryptophan-balanced mixture, 78.2g). The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task. The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.
- Conditions
- Healthy
- Being tested
- oxytocin nasal spray, ATD treatment, intranasal placebo treatment (placebo-control for oxytocin), oral placebo treatment (placebo-control for ATD)
- Keywords
- oxytocin, serotonin, social reward, decision making
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)
ATD treatmentDrug
oral administration of ATD (75.2g) (Acute Tryptophan Depletion)
intranasal placebo treatment (placebo-control for oxytocin)Drug
intranasal administration of placebo nasal spray
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: ATD treatment; Drug: intranasal placebo treatment (placebo-control for oxytocin) |
| 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.
Changes in brain neural activity during the social reward processing as assessed via fMRI
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in response to social reward task in different treatment groups.
Measured: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo
Changes in the resting state as assessed via fMRI
Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups
Measured: Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo
Secondary outcomes (3)
Associations with Personalities of subjects
Personalities of subjects will be measured by a series of scales related to decision making and social reward, such as the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), which measures participants' sensitivity to reward and punishment. SPSRQ is a self-reported instrument that includes 48 yes/no questions divided into two subscales: Sensitivity to Reward (SR, 24 items, ranging from 0 (insensitive) to 24 (sensitive) to reward) and Sensitivity to Punishment (SP, 24 items, ranging from 0 (insensitive) to 24 (sensitive) to punishment). Associations between individual differences in personalities of subjects and differences in behaviors will be measured.
Measured: before 30mins ATD or placebo administration
Behavioral performance in decision making task
Behavioral performance in reversal learning task will be measured and compared between treatment groups.
Measured: approximately 4h after administration of ATD, or placebo, before nasal spray
Behavioral performance in social reward related task
Behavioral performance will be measured and compared between treatment groups
Measured: approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Feb 2018
- Primary completion20 Jun 2019 (estimated)
- Study completion20 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
- NCT03577457
- Sponsor's protocol ID
- SANP-2017-3-ATD
- Status last verified
- Jul 2018
- First submitted
- 5 Feb 2018
- Last updated
- 12 Jul 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 12 Jul 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-reward Brain Networks and Decision Making
- ClinicalTrials.gov ID
- NCT03577457
- Acronym / sponsor ID
- SANP-2017-3-ATD
- Conditions
- Healthy
- Keywords
- oxytocin, serotonin, social reward, decision making
- 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
- 20 Jun 2019 (estimated)
- Study completion
- 20 Jul 2019 (estimated)
- First posted
- 5 Jul 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 primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design
Detailed description
Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human. The aim of this study is to determine whether they interact in those essential human behaviors by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design, in which 4 groups of healthy males will be administered with a random combination of nasal oxytocin (24 international units, IU) or placebo and acute tryptophan depletion (ATD, 75.2g) or placebo (a tryptophan-balanced mixture, 78.2g). The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task. The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.
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: ATD treatment, Drug: intranasal placebo treatment (placebo-control for oxytocin)male 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)
- Healthy 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 |
| ATD treatmentoral administration of ATD (75.2g) (Acute Tryptophan Depletion) | Drug | male oxytocin and ATD group, male placebo and ATD group |
| intranasal placebo treatment (placebo-control for oxytocin)intranasal administration of placebo nasal spray | Drug | male placebo and ATD group, male placebo 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
Changes in brain neural activity during the social reward processing as assessed via fMRI
Time frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in response to social reward task in different treatment groups.
Changes in the resting state as assessed via fMRI
Time frame: Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo
Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups
3 secondary outcomes
Associations with Personalities of subjects
Time frame: before 30mins ATD or placebo administration
Behavioral performance in decision making task
Time frame: approximately 4h after administration of ATD, or placebo, before nasal spray
Behavioral performance in social reward related task
Time frame: approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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 12 Jul 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 Yina Ma, Dr. (+86-15221877059, yma@bnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain neural activity during the social reward processing as assessed via fMRI (time frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo). 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 12 Jul 2018.