HealthyNCT03428906
Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks
A study testing Oxytocin in people with Healthy, run by Beijing Normal University at 1 site in China.
Trial summary
To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males. 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
- 34 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2016to 12 Sep 2017
- 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
Who cannot join
- with MRI Contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
School of Brain and Cognitive Sciences, Beijing Nornal University
Beijing, Beijing Municipality, 100875
About this study
Official title: Effects of Intranasal Oxytocin on Male's Functional Brain Network in Resting-state and Tasks
To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.
Read the detailed description
In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers receive intranasal oxytocin or placebo prior to functional magnetic resonance imaging.Subjects will then go through a decision making task, a emotion judgement task and an eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal oxytocin alter the topology of functional brain network in resting-state and multiple tasks in healthy males. State anxiety and mood are measured before and after experiment as covariates to be controlled.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
intranasally administrated
PlaceboDrug
Also called Saline
intranasally administrated
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (8 IU or 13.44 mg; Syntocinon-spray; Novartis, Switzerland) . Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional network organization alterations in brain under resting state fMRI after drug administration
Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional network organization in brain under eight minutes resting state will be detected and compared between oxytocin and placebo group.
Measured: 70~85 minutes after drug administration
Behavior,brain activities and representation patterns in the emotional judgement task after drug administration
Friend or Foe Task is used to measure the verbal versus nonverbal emotional judgement of subjects. Both the response of subjects and the brain activity are recorded in the task. How oxytocin influences the relationship between subjects' behavior and representation pattern of emotional judgement will be investigated through RSA(representation similarity analysis) of brain pattern.
Measured: 60~75 minutes after drug administration
Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration
Two-Stage Decision Making Task is used to measure the model-based and model-free decision making process of subjects. The degree of model-based will be calculated by Computational modelling of Subjects' decision making process, and entering as modulation parameter in the OT effect on dynamic brain seed-based and network-based connectivity pattern.
Measured: 35~60 minutes after drug administration
Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration
The functional brain activity in resting state, emotional judgement and decision making task will be compared. Both the functional segregation and integration will be measured using graph theory and network connectivity analysis to discover the OT effect on brain network organization across multiple cognitive states.
Measured: 60~85 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 posted12 Feb 2018
- Study start24 May 2016
- Primary completion25 Apr 2017
- Study completion12 Sep 2017
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
- Crossover
- Model description
- The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ma, yina, Beijing Normal University
- Investigators
- Yina Ma, PhD, Principal investigator, School of Brain and Cognitive Sciences, Beijing Nornal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428906
- Sponsor's protocol ID
- IN-OT functional network
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 12 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 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Oxytocin on Male's Functional Brain Network in Resting-state and Tasks
- ClinicalTrials.gov ID
- NCT03428906
- Acronym / sponsor ID
- IN-OT functional network
- Conditions
- Healthy
- Keywords
- intranasal oxytocin, functional brain network, multiple tasks, resting state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 24 May 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 12 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.
To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.
Detailed description
In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers receive intranasal oxytocin or placebo prior to functional magnetic resonance imaging.Subjects will then go through a decision making task, a emotion judgement task and an eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal oxytocin alter the topology of functional brain network in resting-state and multiple tasks in healthy males. State anxiety and mood are measured before and after experiment as covariates to be controlled.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (8 IU or 13.44 mg; Syntocinon-spray; Novartis, Switzerland) . |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril. |
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 (1 listed)
- with MRI Contraindications
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 |
|---|---|---|
| Oxytocinintranasally administrated | Drug | Oxytocin |
| PlaceboAlso: Salineintranasally administrated | Drug | Placebo |
Primary outcome
Functional network organization alterations in brain under resting state fMRI after drug administration
Time frame: 70~85 minutes after drug administration
Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional network organization in brain under eight minutes resting state will be detected and compared between oxytocin and placebo group.
Behavior,brain activities and representation patterns in the emotional judgement task after drug administration
Time frame: 60~75 minutes after drug administration
Friend or Foe Task is used to measure the verbal versus nonverbal emotional judgement of subjects. Both the response of subjects and the brain activity are recorded in the task. How oxytocin influences the relationship between subjects' behavior and representation pattern of emotional judgement will be investigated through RSA(representation similarity analysis) of brain pattern.
Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration
Time frame: 35~60 minutes after drug administration
Two-Stage Decision Making Task is used to measure the model-based and model-free decision making process of subjects. The degree of model-based will be calculated by Computational modelling of Subjects' decision making process, and entering as modulation parameter in the OT effect on dynamic brain seed-based and network-based connectivity pattern.
Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration
Time frame: 60~85 minutes after drug administration
The functional brain activity in resting state, emotional judgement and decision making task will be compared. Both the functional segregation and integration will be measured using graph theory and network connectivity analysis to discover the OT effect on brain network organization across multiple cognitive states.
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 12 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.
Yina Ma, PhD principal investigator
School of Brain and Cognitive Sciences, Beijing Nornal University
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 Beijing Normal University 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 1 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 12 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?
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?
Functional network organization alterations in brain under resting state fMRI after drug administration (time frame: 70~85 minutes after drug administration). The study lists 4 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 Feb 2018.