HealthyNCT04320706
Oral Oxytocin Modulation of Responses to Emotional Stimuli
A study testing Oral Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing. Read more about this study
- Who is it for?
- Ages 17 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral Oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2020to 1 Mar 2021
- 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 17 to 32 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy subjects without any past or present psychiatric or neurological disorders
Who cannot join
- History of brain injury
- Head trauma
- Substance abuse
- Medication
- fMRI contraindications (e.g. metal implants)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
Weihua Zhao, PhD
About this study
Official title: Oral Oxytocin Modulation of Brain and Behavioral Responses to Emotional Stimuli in Healthy Men
The main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing.
Read the detailed description
A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. The investigators hypothesize that one method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the current double-blind, between-subject, placebo controlled study 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects will be required to complete both face emotion and emotional scene processing tasks during fMRI scanning. After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition. Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations. All subjects will be asked to complete a range of questionnaires before treatment to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), and Interpersonal Reactivity Index (IRI).
- Conditions
- Healthy
- Being tested
- Oral Oxytocin, Oral Placebo
- Keywords
- oral Oxytocin, emotional processing, anxiety, reward
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral OxytocinDrug
Administration of oxytocin (24 international units) orally
Oral PlaceboDrug
Administration of placebo orally
| Study group | Role | What they receive |
|---|---|---|
| Oral Oxytocin | Experimental | Oxytocin orally (24 IU) Receives: Drug: Oral Oxytocin |
| Oral Placebo | Placebo comparator | Placebo orally (identical ingredients, except the active agent) Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI
Comparison of neural activation as assessed by functional MRI on the whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (happy, neutral, angry, fear) ANOVAs and emotion-specific comparisons between the treatment groups. We hypothesized that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
Measured: 45-90 minutes after treatment
Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI
Comparison of neural activation as assessed by functional MRI on whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (neutral, positive, negative) ANOVAs and emotion-specific post hoc comparisons between the treatment groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
Measured: 45-90 minutes after treatment
Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli
Comparison of behavioral ratings of valence, arousal and intensity (9-point Likert scale) for emotional face and social scene stimuli presented again post-scan will be performed in oxytocin versus placebo control groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on behavioral ratings of positive and negative valence emotional stimuli. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively in a different pattern of functional effects.
Measured: 45-115 minutes after treatment
Change in blood oxytocin concentrations following oral administration of oxytocin
Changes in blood concentrations of oxytocin from baseline after oral oxytocin treatment will be assessed by comparison with the placebo group. We hypothesize that oral oxytocin should produce a significant increase in blood oxytocin concentrations after 30 minutes.
Measured: 30 minutes before treatment and 30 minutes after treatment
Secondary outcomes (3)
Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings
Correlations between neural responses changes and post-scan behavioral ratings of positive and negative valence stimuli will be performed using Pearson correlation in both oxytocin and placebo groups. We hypothesize that neural responses and behavioral ratings will be correlated.
Measured: 45-115 minutes after treatment
Correlations between neural responses/functional connectivity in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin
Correlations between neural responses in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin will be performed using Pearson correlation in both oxytocin and placebo groups. We hypothesize that neural responses to emotional stimuli will correlate with basal and/or oral administration evoked oxytocin concentrations.
Measured: 30 minutes before treatment to 90 minutes after treatment
Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations
Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations will be performed using Pearson correlation in both oxytocin and placebo groups. We hypothesize that behavioral ratings to emotional stimuli will correlate with basal and/or oral administration evoked oxytocin concentrations.
Measured: 30 minutes before treatment to 115 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start20 Feb 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Mar 2021 (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
- Model description
- Randomized placebo-controlled double-blind between-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320706
- Sponsor's protocol ID
- UESTC-neuSCAN-60
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Oxytocin Modulation of Brain and Behavioral Responses to Emotional Stimuli in Healthy Men
- ClinicalTrials.gov ID
- NCT04320706
- Acronym / sponsor ID
- UESTC-neuSCAN-60
- Conditions
- Healthy
- Keywords
- oral Oxytocin, emotional processing, anxiety, reward
- 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
- 20 Feb 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 25 Mar 2020 (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 main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing.
Detailed description
A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. The investigators hypothesize that one method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the current double-blind, between-subject, placebo controlled study 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects will be required to complete both face emotion and emotional scene processing tasks during fMRI scanning. After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition. Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations. All subjects will be asked to complete a range of questionnaires before treatment to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), and Interpersonal Reactivity Index (IRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double-blind between-subject design
| Arm | Type | Receives |
|---|---|---|
| Oral Oxytocin | Experimental | Drug: Oral OxytocinOxytocin orally (24 IU) |
| Oral Placebo | Placebo comparator | Drug: Oral PlaceboPlacebo orally (identical ingredients, except the active agent) |
Who may qualify
- Ages
- 17 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy subjects without any past or present psychiatric or neurological disorders
Key exclusion criteria (5 listed)
- History of brain injury
- Head trauma
- Substance abuse
- Medication
- fMRI contraindications (e.g. metal implants)
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 |
|---|---|---|
| Oral OxytocinAdministration of oxytocin (24 international units) orally | Drug | Oral Oxytocin |
| Oral PlaceboAdministration of placebo orally | Drug | Oral Placebo |
Primary outcome
Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI
Time frame: 45-90 minutes after treatment
Comparison of neural activation as assessed by functional MRI on the whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (happy, neutral, angry, fear) ANOVAs and emotion-specific comparisons between the treatment groups. We hypothesized that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI
Time frame: 45-90 minutes after treatment
Comparison of neural activation as assessed by functional MRI on whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (neutral, positive, negative) ANOVAs and emotion-specific post hoc comparisons between the treatment groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli
Time frame: 45-115 minutes after treatment
Comparison of behavioral ratings of valence, arousal and intensity (9-point Likert scale) for emotional face and social scene stimuli presented again post-scan will be performed in oxytocin versus placebo control groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on behavioral ratings of positive and negative valence emotional stimuli. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively in a different pattern of functional effects.
Change in blood oxytocin concentrations following oral administration of oxytocin
Time frame: 30 minutes before treatment and 30 minutes after treatment
Changes in blood concentrations of oxytocin from baseline after oral oxytocin treatment will be assessed by comparison with the placebo group. We hypothesize that oral oxytocin should produce a significant increase in blood oxytocin concentrations after 30 minutes.
3 secondary outcomes
Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings
Time frame: 45-115 minutes after treatment
Correlations between neural responses/functional connectivity in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin
Time frame: 30 minutes before treatment to 90 minutes after treatment
Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations
Time frame: 30 minutes before treatment to 115 minutes after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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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.
Keith Kendrick, PhD 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 study testing Oral 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 5 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 31 Mar 2020. 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, PhD (+86 2861 830 811, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI (time frame: 45-90 minutes after treatment). 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 31 Mar 2020.