HealthyNCT05532501
The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes
A study testing Oral Oxytocin and Intranasal Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm. 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?
- Oral Oxytocin and Intranasal Oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 20 Feb 2023
- 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 any past or present psychiatric or neurological disorders
Who cannot join
- 1. History of brain injury 2. Head trauma 3. Substance abuse 4. Medication
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: Differential Modulation of Neural and Behavioral Responses to Emotional Scenes by Intranasal and Oral Oxytocin Administration in Healthy Men
The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.
Read the detailed description
Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli. However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes. In the current randomized, double-blind, between-subjects, placebo-controlled study, 160 healthy male subjects will be recruited and receive treatment either oxytocin (24IU, orally/intranasally) or placebo (orally/intranasally). Prior to treatment, all subjects will complete a number of questionnaires to control for potential group differences in potential confounders in terms of personality traits and mood, including: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), Interpersonal Reactivity Index (IRI). Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood. Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes). After fMRI scanning, subjects will be required to rate emotional stimuli presented during the scan on valence, intensity, and arousal using 1-9 point Self-Assessment Manikin (SAM) scales.
- Conditions
- Healthy
- Being tested
- Oral Oxytocin, Intranasal Oxytocin, Oral placebo, Intranasal placebo
- Keywords
- Oral, Intranasal, Oxytocin, Emotional processing
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
Administer oxytocin (24 IU) orally, 6 individual 0.1 ml puffs (4 IU/0.1ml) on the tongue (lingual), one every 30 seconds
Intranasal OxytocinDrug
Also called Oxytocin intranasally
Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0.1ml), three puffs per nostril one every 30 seconds
Oral placeboDrug
Also called Placebo orally
Administer placebo orally, 6 individual 0.1 ml puffs on the tongue (lingual), one every 30 seconds.
Intranasal placeboDrug
Also called Placebo intranasally
Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Oral Oxytocin | Active comparator | Administer oxytocin (24 IU) orally Receives: Drug: Oral Oxytocin |
| Intranasal Oxytocin | Active comparator | Administer oxytocin (24 IU) intranasally Receives: Drug: Intranasal Oxytocin |
| Oral placebo | Placebo comparator | Administer placebo orally (identical ingredients, except the active agent) Receives: Drug: Oral placebo |
| Intranasal placebo | Placebo comparator | Administer placebo intranasally (identical ingredients, except the active agent) Receives: Drug: Intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes.
Comparison of whole brain neural (fMRI scanning) activation differences between oral and intranasal oxytocin administration to emotional scenes will be performed using a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and valence of emotional scenes (positive/negative/neutral) as within-subject factor, post-hoc comparisons will be conducted to further disentangle the significant interactions observed after the mixed ANOVA.
Measured: 45~70 minutes after treatment
Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.
Differences in behavioral ratings of valence (1-9 point Self-Assessmen-Manikin (SAM) scale, 1 means very negative, 9 means very positive, 5 means neutral), intensity (1-9 point SAM scale, 1 means mild, 9 means strong), and arousal (1-9 point SAM scale, 1 means not aroused at all, 9 means very aroused) of emotional scene stimuli between oral oxytocin and intranasal oxytocin groups will be examined using mixed ANOVAs, respectively.
Measured: 70~90 minutes after treatment
Secondary outcomes (5)
Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.
Comparison of functional connectivity (fMRI scanning) differences between oral and intranasal oxytocin administration to emotional scenes by means of a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and emotional scene (positive/negative/neutral) as within-subject factor, post-hoc comparisons was conducted to further disentangle the significant interaction observed after mixed ANOVA.
Measured: 45~70 minutes after treatment
Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.
Pearson correlation tests will be used to compute correlations between any significant neural and behavioral effects of treatment.
Measured: 45~90 minutes after treatment
Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.
Pearson correlation tests will be used to compute correlations between any significant neural and behavioral effects of treatment.
Measured: 45~90 minutes after treatment
Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.
Comparisons of whole brain rsfMRI will be performed using an ANOVA with route (oral/intranasal) and treatment (oxytocin/placebo) as between-subject factors. Post-hoc comparisons will be used to disentangle significant interactions observed in the ANOVA.
Measured: 45~70 minutes after treatment
Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.
The Positive Affect Negative Affect Schedule measures both positive and negative mood in a person. The Positive Affect score ranges from 10-50, with higher scores representing higher levels of positive affect. The Negative Affect scores range from 10-50, with lower scores representing lower levels of negative affect. The differences in PANAS scores at each time-point between treatment groups will be analyzed using mixed ANOVAs.
Measured: 0~70 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start20 Sep 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Feb 2023 (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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith M Kendrick, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532501
- Sponsor's protocol ID
- UESTC-neuSCAN-91
- Status last verified
- Jul 2022
- First submitted
- 4 Sep 2022
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Modulation of Neural and Behavioral Responses to Emotional Scenes by Intranasal and Oral Oxytocin Administration in Healthy Men
- ClinicalTrials.gov ID
- NCT05532501
- Acronym / sponsor ID
- UESTC-neuSCAN-91
- Conditions
- Healthy
- Keywords
- Oral, Intranasal, Oxytocin, Emotional processing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 8 Sep 2022 (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 will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.
Detailed description
Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli. However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes. In the current randomized, double-blind, between-subjects, placebo-controlled study, 160 healthy male subjects will be recruited and receive treatment either oxytocin (24IU, orally/intranasally) or placebo (orally/intranasally). Prior to treatment, all subjects will complete a number of questionnaires to control for potential group differences in potential confounders in terms of personality traits and mood, including: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), Interpersonal Reactivity Index (IRI). Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood. Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes). After fMRI scanning, subjects will be required to rate emotional stimuli presented during the scan on valence, intensity, and arousal using 1-9 point Self-Assessment Manikin (SAM) scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized placebo-controlled double-blind between-subject design
| Arm | Type | Receives |
|---|---|---|
| Oral Oxytocin | Active comparator | Drug: Oral OxytocinAdminister oxytocin (24 IU) orally |
| Intranasal Oxytocin | Active comparator | Drug: Intranasal OxytocinAdminister oxytocin (24 IU) intranasally |
| Oral placebo | Placebo comparator | Drug: Oral placeboAdminister placebo orally (identical ingredients, except the active agent) |
| Intranasal placebo | Placebo comparator | Drug: Intranasal placeboAdminister placebo intranasally (identical ingredients, except the active agent) |
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 any past or present psychiatric or neurological disorders
Key exclusion criteria (1 listed)
- 1. History of brain injury 2. Head trauma 3. Substance abuse 4. Medication
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 orallyAdminister oxytocin (24 IU) orally, 6 individual 0.1 ml puffs (4 IU/0.1ml) on the tongue (lingual), one every 30 seconds | Drug | Oral Oxytocin |
| Intranasal OxytocinAlso: Oxytocin intranasallyAdminister oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0.1ml), three puffs per nostril one every 30 seconds | Drug | Intranasal Oxytocin |
| Oral placeboAlso: Placebo orallyAdminister placebo orally, 6 individual 0.1 ml puffs on the tongue (lingual), one every 30 seconds. | Drug | Oral placebo |
| Intranasal placeboAlso: Placebo intranasallyAdminister placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds | Drug | Intranasal placebo |
Primary outcome
Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes.
Time frame: 45~70 minutes after treatment
Comparison of whole brain neural (fMRI scanning) activation differences between oral and intranasal oxytocin administration to emotional scenes will be performed using a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and valence of emotional scenes (positive/negative/neutral) as within-subject factor, post-hoc comparisons will be conducted to further disentangle the significant interactions observed after the mixed ANOVA.
Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.
Time frame: 70~90 minutes after treatment
Differences in behavioral ratings of valence (1-9 point Self-Assessmen-Manikin (SAM) scale, 1 means very negative, 9 means very positive, 5 means neutral), intensity (1-9 point SAM scale, 1 means mild, 9 means strong), and arousal (1-9 point SAM scale, 1 means not aroused at all, 9 means very aroused) of emotional scene stimuli between oral oxytocin and intranasal oxytocin groups will be examined using mixed ANOVAs, respectively.
5 secondary outcomes
Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.
Time frame: 45~70 minutes after treatment
Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.
Time frame: 45~90 minutes after treatment
Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.
Time frame: 45~90 minutes after treatment
Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.
Time frame: 45~70 minutes after treatment
Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.
Time frame: 0~70 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
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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 and Intranasal 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 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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?
Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes. (time frame: 45~70 minutes 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 Sep 2022.