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Clinical Trials/NCT05532501
NCT05532501
Unknown
Not Applicable

Differential Modulation of Neural and Behavioral Responses to Emotional Scenes by Intranasal and Oral Oxytocin Administration in Healthy Men

University of Electronic Science and Technology of China1 site in 1 country160 target enrollmentSeptember 20, 2022

Overview

Phase
Not Applicable
Intervention
Oral Oxytocin
Conditions
Healthy
Sponsor
University of Electronic Science and Technology of China
Enrollment
160
Locations
1
Primary Endpoint
Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2022
End Date
February 20, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • History of brain injury
  • Head trauma
  • Substance abuse

Arms & Interventions

Oral Oxytocin

Administer oxytocin (24 IU) orally

Intervention: Oral Oxytocin

Intranasal Oxytocin

Administer oxytocin (24 IU) intranasally

Intervention: Intranasal Oxytocin

Oral placebo

Administer placebo orally (identical ingredients, except the active agent)

Intervention: Oral placebo

Intranasal placebo

Administer placebo intranasally (identical ingredients, except the active agent)

Intervention: Intranasal placebo

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.(45~90 minutes after treatment)
  • Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.(45~90 minutes after treatment)
  • Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.(45~70 minutes after treatment)
  • Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.(0~70 minutes)
  • Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.(45~70 minutes after treatment)

Study Sites (1)

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