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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oral Oxytocin
* Drug: Oral Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo-controlled double-blind between-subject design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Oxytocin<br>Oxytocin orally (24 IU) | Drug: Oral Oxytocin<br>* Administration of oxytocin (24 international units) orally<br>* Other names: Oxytocin Orally;|
| Placebo Comparator: Oral Placebo<br>Placebo orally (identical ingredients, except the active agent) | Drug: Oral Placebo<br>* Administration of placebo orally<br>* Other names: Placebo Orally;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 45 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 45 minutes after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Oxytocin, Emotional processing, Anxiety, Reward