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Clinical Trials/NCT05073939
NCT05073939
Unknown
Not Applicable

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

University of Electronic Science and Technology of China1 site in 1 country80 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Oral Oxytocin
Conditions
Healthy
Sponsor
University of Electronic Science and Technology of China
Enrollment
80
Locations
1
Primary Endpoint
Effects of oral oxytocin on behavioral ratings of emotional faces stimuli
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
January 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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

Keith Kendrick

Principal Investigator

University of Electronic Science and Technology of China

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
  • Medication
  • fMRI contraindications (e.g. metal implants)

Arms & Interventions

Oral Oxytocin

Oxytocin orally (24 IU)

Intervention: Oral Oxytocin

Oral Placebo

Placebo orally (identical ingredients, except the active agent)

Intervention: Oral Placebo

Outcomes

Primary Outcomes

Effects of oral oxytocin on behavioral ratings of emotional faces stimuli

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Gender differences in behavioral responses to affective scenes stimuli(45 minutes after treatment)
  • Interaction effect between gender and treatment on neural response to emotional faces stimuli(45 minutes after treatment)
  • The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli(Before treatment to 150 minutes after treatment)
  • Gender differences in plasma oxytocin concentrations changes(Before and 30 minutes after treatment)
  • The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli(Before treatment to 150 minutes after treatment)
  • The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli(Before treatment to 150 minutes after treatment)
  • Gender differences in behavioral responses to emotional faces stimuli(45 minutes after treatment)
  • Interaction effect between gender and treatment on plasma oxytocin concentrations changes(Before and 30 minutes after treatment)
  • Gender differences in neural response to affective scenes stimuli(45 minutes after treatment)
  • Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli(45 minutes after treatment)
  • The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli(Before treatment to 150 minutes after treatment)
  • Gender differences in neural response to emotional faces stimuli(45 minutes after treatment)
  • Interaction effect between gender and treatment on neural response to affective scenes stimuli(45 minutes after treatment)
  • Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli(45 minutes after treatment)

Study Sites (1)

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