Effect of Oral Oxytocin on Women's Response to Emotional Stimuli

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Oral Oxytocin; Drug: Oral Placebo

• Registration Number: NCT05073939
• Lead Sponsor: University of Electronic Science and Technology of China

Brief 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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-09-18
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-12
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-21
• Primary Completion: 2021-11-30
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• History of brain injury
• Head trauma
• Substance abuse
• Medication
• fMRI contraindications (e.g. metal implants)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Oxytocin	Oral Oxytocin	Oxytocin orally (24 IU)
Oral Placebo	Oral Placebo	Placebo orally (identical ingredients, except the active agent)

Primary Outcome Measures

Name	Time	Method
Effects of oral oxytocin on behavioral ratings of emotional faces stimuli	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 neural responses to affective scenes assessed by affective scenes processing task fMRI	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 neural responses to emotional faces assessed by emotional faces processing task fMRI	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.
Changes in blood oxytocin concentrations after oral oxytocin	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 behavioral ratings of affective scenes stimuli	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.

Secondary Outcome Measures

Name	Time	Method
Gender differences in behavioral responses to affective scenes stimuli	45 minutes after treatment	Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced post-scan behavioral responses to affective scenes stimuli will be investigated.
Interaction effect between gender and treatment on neural response to emotional faces stimuli	45 minutes after treatment	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.
The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli	Before treatment to 150 minutes after treatment	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.
Gender differences in plasma oxytocin concentrations changes	Before and 30 minutes after treatment	Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced plasma oxytocin concentrations changes will be investigated.
The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli	Before treatment to 150 minutes after treatment	Correlation analysis between plasma oxytocin concentrations changes and post-scan behavioral ratings of emotional faces stimuli will be explored across two treatment groups.
The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli	Before treatment to 150 minutes after treatment	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.
Gender differences in behavioral responses to emotional faces stimuli	45 minutes after treatment	Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced post-scan behavioral responses to emotional faces stimuli will be investigated.
Interaction effect between gender and treatment on plasma oxytocin concentrations changes	Before and 30 minutes after treatment	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.
Gender differences in neural response to affective scenes stimuli	45 minutes after treatment	Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced neural responses/functional connectivity to affective scenes stimuli will be investigated.
Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli	45 minutes after treatment	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.
The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli	Before treatment to 150 minutes after treatment	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.
Gender differences in neural response to emotional faces stimuli	45 minutes after treatment	Gender differences (male's data from ClinicalTrials.gov NCT04320706) in oral oxytocin-induced neural responses/functional connectivity to emotional faces stimuli will be investigated.
Interaction effect between gender and treatment on neural response to affective scenes stimuli	45 minutes after treatment	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.
Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli	45 minutes after treatment	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.

Trial Locations

Locations (1)

school of life science and technology, University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China