The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes

September 4, 2022 updated by: University of Electronic Science and Technology of China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • School of Life science and Technology, University of Electronic Science and Technology of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

  • 1. History of brain injury 2. Head trauma 3. Substance abuse 4. Medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Oral Oxytocin
Administer oxytocin (24 IU) orally
Drug: Oral Oxytocin
Administer oxytocin (24 IU) orally, 6 individual 0.1 ml puffs (4 IU/0.1ml) on the tongue (lingual), one every 30 seconds
Other Names:
  • Oxytocin orally
Active Comparator: Intranasal Oxytocin
Administer oxytocin (24 IU) intranasally
Drug: Intranasal Oxytocin
Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0.1ml), three puffs per nostril one every 30 seconds
Other Names:
  • Oxytocin intranasally
Placebo Comparator: Oral placebo
Administer placebo orally (identical ingredients, except the active agent)
Drug: Oral placebo
Administer placebo orally, 6 individual 0.1 ml puffs on the tongue (lingual), one every 30 seconds.
Other Names:
  • Placebo orally
Placebo Comparator: Intranasal placebo
Administer placebo intranasally (identical ingredients, except the active agent)
Drug: Intranasal placebo
Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds
Other Names:
  • Placebo intranasally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
45~70 minutes after treatment
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.
70~90 minutes after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
Pearson correlation tests will be used to compute correlations between any significant neural and behavioral effects of treatment.
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
Pearson correlation tests will be used to compute correlations between any significant neural and behavioral effects of treatment.
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
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.
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
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.
0~70 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UESTC-neuSCAN-91

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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