HealthyNCT05073939
Effect of Oral Oxytocin on Women's Response 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) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women 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
- 1 Apr 2021to 30 Jan 2022
- 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
- Women only
- Healthy volunteers accepted
- 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, 611731
Weihua Zhao, PhD
About this study
Official title: Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women
The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes.
Read the detailed description
All subjects will complete a series of questionnaires firstly 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), Positive and Negative Affect Schedule (PANAS). PANAS is administered before and after oral administration and after functional magnetic resonance imaging (fMRI) scanning. In the current double-blind, between-subject, placebo-controlled study 80 healthy female subjects will be recruited and receive oral administration either oxytocin (24IU) or placebo. Blood samples are collected twice before and 30 minutes after oral administration to assess the plasma OXT concentrations change. 45 minutes after oral administration subjects will be required to finish fMRI scanning including resting-state fMRI task, emotional face task (happy, fear, angry and neutral faces), affective scene task (NAPS, Nencki affective picture system, positive, neutral, and negative-valence scenes). After fMRI scanning, subjects will be required to rate valence, intensity, and arousal responses (Likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fMRI scanning.
- 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
Also called Oxytocin Orally
Administration of oxytocin (24 international units) orally
Oral PlaceboDrug
Also called Placebo Orally
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.
Changes in blood oxytocin concentrations after oral oxytocin
Changes in blood oxytocin concentrations will be assessed across two groups between baseline and 30 minutes after oral treatment administration.
Measured: Before and 30 minutes after treatment
Effects of oral oxytocin on neural responses to emotional faces assessed by emotional faces processing task fMRI
Comparison of neural activations between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo)× faces(happy, neutral, angry, fear) ANOVA and emotional face-specific post-hoc comparisons between the treatment groups.
Measured: 45 minutes after treatment
Effects of oral oxytocin on neural responses to affective scenes assessed by affective scenes processing task fMRI
Comparison of neural activations as assessed by functional MRI on the whole-brain level between oral oxytocin and placebo by means of treatment (oxytocin, placebo) × scenes(neutral, positive, negative) ANOVA and scene-specific post-hoc comparisons between the treatment groups.
Measured: 45 minutes after treatment
Effects of oral oxytocin on behavioral ratings of emotional faces stimuli
Differences in behavioral ratings of valence(1-9-point Likert scale, 1 means very negative,9 means very positive, 5 means neutral), intensity (1-9-point Likert scale, 1 means mild, 9 means strong), and arousal(1-9-point Likert scale, 1 means sleepy, 9 means alert) for emotional faces stimuli between oxytocin group and placebo group.
Measured: 45 minutes after treatment
Effects of oral oxytocin on behavioral ratings of affective scenes stimuli
Differences in behavioral ratings of valence(1-9-point Likert scale, 1 means very negative,9 means very positive, 5 means neutral), intensity (1-9-point Likert scale, 1 means mild, 9 means strong), and arousal(1-9-point Likert scale, 1 means sleepy, 9 means alert) of affective scenes stimuli between oxytocin group and placebo group.
Measured: 45 minutes after treatment
Secondary outcomes (14)
The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli
Correlation analysis between oral oxytocin-induced plasma oxytocin concentrations changes and oral oxytocin-induced neural responses/functional connectivity changes of emotional faces will be explored across two treatment groups.
Measured: Before treatment to 150 minutes after treatment
The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli
Correlation analysis between oral oxytocin-induced plasma oxytocin concentrations changes and oral oxytocin-induced neural responses/functional connectivity changes of affective scenes stimuli will be explored across two treatment groups.
Measured: Before treatment to 150 minutes after treatment
The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli
Correlation analysis between plasma oxytocin concentrations changes and post-scan behavioral ratings of emotional faces stimuli will be explored across two treatment groups.
Measured: Before treatment to 150 minutes after treatment
The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli
Correlation analysis between oral oxytocin-induced plasma oxytocin concentrations changes and post-scan behavioral ratings of affective scenes stimuli will be explored across two treatment groups.
Measured: Before treatment to 150 minutes after treatment
Gender differences in plasma oxytocin concentrations changes
Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced plasma oxytocin concentrations changes will be investigated.
Measured: Before and 30 minutes after treatment
Gender differences in neural response to emotional faces stimuli
Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced neural responses/functional connectivity to emotional faces stimuli will be investigated.
Measured: 45 minutes after treatment
Gender differences in neural response to affective scenes stimuli
Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced neural responses/functional connectivity to affective scenes stimuli will be investigated.
Measured: 45 minutes after treatment
Gender differences in behavioral responses to emotional faces stimuli
Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced post-scan behavioral responses to emotional faces stimuli will be investigated.
Measured: 45 minutes after treatment
Gender differences in behavioral responses to affective scenes stimuli
Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced post-scan behavioral responses to affective scenes stimuli will be investigated.
Measured: 45 minutes after treatment
Interaction effect between gender and treatment on plasma oxytocin concentrations changes
The interaction effect between gender(male/female, male's data from ClinicalTrials.gov NCT04320706) and treatment(OXT/PLC) on plasma oxytocin concentrations changes will be investigated.
Measured: Before and 30 minutes after treatment
Interaction effect between gender and treatment on neural response to emotional faces stimuli
The interaction effect between gender(male/female, male's data from ClinicalTrials.gov NCT04320706) and treatment(OXT/PLC) on neural response/functional connectivity to emotional faces stimuli will be investigated.
Measured: 45 minutes after treatment
Interaction effect between gender and treatment on neural response to affective scenes stimuli
The interaction effect between gender(male/female, male's data from ClinicalTrials.gov NCT04320706) and treatment(OXT/PLC) on neural response/functional connectivity to affective scenes stimuli will be investigated.
Measured: 45 minutes after treatment
Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli
The interaction effect between gender(male/female, male's data from ClinicalTrials.gov NCT04320706) and treatment(OXT/PLC) on post-scan behavioral ratings of emotional faces stimuli will be investigated.
Measured: 45 minutes after treatment
Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli
The interaction effect between gender(male/female, male's data from ClinicalTrials.gov NCT04320706) and treatment(OXT/PLC) on post-scan behavioral ratings of affective scenes stimuli will be investigated.
Measured: 45 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 posted12 Oct 2021
- Study start1 Apr 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Jan 2022 (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 M Kendrick, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073939
- Sponsor's protocol ID
- UESTC-neuSCAN-84
- Status last verified
- Oct 2021
- First submitted
- 18 Sep 2021
- Last updated
- 21 Oct 2021
- 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 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women
- ClinicalTrials.gov ID
- NCT05073939
- Acronym / sponsor ID
- UESTC-neuSCAN-84
- 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
- 1 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 12 Oct 2021 (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) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes.
Detailed description
All subjects will complete a series of questionnaires firstly 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), Positive and Negative Affect Schedule (PANAS). PANAS is administered before and after oral administration and after functional magnetic resonance imaging (fMRI) scanning. In the current double-blind, between-subject, placebo-controlled study 80 healthy female subjects will be recruited and receive oral administration either oxytocin (24IU) or placebo. Blood samples are collected twice before and 30 minutes after oral administration to assess the plasma OXT concentrations change. 45 minutes after oral administration subjects will be required to finish fMRI scanning including resting-state fMRI task, emotional face task (happy, fear, angry and neutral faces), affective scene task (NAPS, Nencki affective picture system, positive, neutral, and negative-valence scenes). After fMRI scanning, subjects will be required to rate valence, intensity, and arousal responses (Likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fMRI scanning.
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
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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 OxytocinAlso: Oxytocin OrallyAdministration of oxytocin (24 international units) orally | Drug | Oral Oxytocin |
| Oral PlaceboAlso: Placebo OrallyAdministration of placebo orally | Drug | Oral Placebo |
Primary outcome
Changes in blood oxytocin concentrations after oral oxytocin
Time frame: Before and 30 minutes after treatment
Changes in blood oxytocin concentrations will be assessed across two groups between baseline and 30 minutes after oral treatment administration.
Effects of oral oxytocin on neural responses to emotional faces assessed by emotional faces processing task fMRI
Time frame: 45 minutes after treatment
Comparison of neural activations between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo)× faces(happy, neutral, angry, fear) ANOVA and emotional face-specific post-hoc comparisons between the treatment groups.
Effects of oral oxytocin on neural responses to affective scenes assessed by affective scenes processing task fMRI
Time frame: 45 minutes after treatment
Comparison of neural activations as assessed by functional MRI on the whole-brain level between oral oxytocin and placebo by means of treatment (oxytocin, placebo) × scenes(neutral, positive, negative) ANOVA and scene-specific post-hoc comparisons between the treatment groups.
Effects of oral oxytocin on behavioral ratings of emotional faces stimuli
Time frame: 45 minutes after treatment
Differences in behavioral ratings of valence(1-9-point Likert scale, 1 means very negative,9 means very positive, 5 means neutral), intensity (1-9-point Likert scale, 1 means mild, 9 means strong), and arousal(1-9-point Likert scale, 1 means sleepy, 9 means alert) for emotional faces stimuli between oxytocin group and placebo group.
Effects of oral oxytocin on behavioral ratings of affective scenes stimuli
Time frame: 45 minutes after treatment
Differences in behavioral ratings of valence(1-9-point Likert scale, 1 means very negative,9 means very positive, 5 means neutral), intensity (1-9-point Likert scale, 1 means mild, 9 means strong), and arousal(1-9-point Likert scale, 1 means sleepy, 9 means alert) of affective scenes stimuli between oxytocin group and placebo group.
14 secondary outcomes
The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli
Time frame: Before treatment to 150 minutes after treatment
The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli
Time frame: Before treatment to 150 minutes after treatment
The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli
Time frame: Before treatment to 150 minutes after treatment
The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli
Time frame: Before treatment to 150 minutes after treatment
Gender differences in plasma oxytocin concentrations changes
Time frame: Before and 30 minutes after treatment
Gender differences in neural response to emotional faces stimuli
Time frame: 45 minutes after treatment
Gender differences in neural response to affective scenes stimuli
Time frame: 45 minutes after treatment
Gender differences in behavioral responses to emotional faces stimuli
Time frame: 45 minutes after treatment
Gender differences in behavioral responses to affective scenes stimuli
Time frame: 45 minutes after treatment
Interaction effect between gender and treatment on plasma oxytocin concentrations changes
Time frame: Before and 30 minutes after treatment
Interaction effect between gender and treatment on neural response to emotional faces stimuli
Time frame: 45 minutes after treatment
Interaction effect between gender and treatment on neural response to affective scenes stimuli
Time frame: 45 minutes after treatment
Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli
Time frame: 45 minutes after treatment
Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli
Time frame: 45 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 21 Oct 2021.
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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 M 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 21 Oct 2021. 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 Keith M Kendrick, PhD (86-28-61830811, k.kendrick.uestc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood oxytocin concentrations after oral oxytocin (time frame: Before and 30 minutes after treatment). The study lists 5 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 21 Oct 2021.