Clinical trial NCT05073939: Effect of Oral Oxytocin on Women's Response to Emotional Stimuli
Official title: Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Oral Oxytocin
Emotional processing
Anxiety
Reward
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled double-blind between-subject design
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Changes in blood oxytocin concentrations after oral oxytocin
timeFrame: Before and 30 minutes after treatment
measure: Effects of oral oxytocin on neural responses to emotional faces assessed by emotional faces processing task fMRI
timeFrame: 45 minutes after treatment
measure: Effects of oral oxytocin on neural responses to affective scenes assessed by affective scenes processing task fMRI
timeFrame: 45 minutes after treatment
measure: Effects of oral oxytocin on behavioral ratings of emotional faces stimuli
timeFrame: 45 minutes after treatment
measure: Effects of oral oxytocin on behavioral ratings of affective scenes stimuli
timeFrame: 45 minutes after treatment
Secondary outcomes:
measure: The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli
timeFrame: Before treatment to 150 minutes after treatment
measure: The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli
timeFrame: Before treatment to 150 minutes after treatment
measure: The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli
timeFrame: Before treatment to 150 minutes after treatment
measure: The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli
timeFrame: Before treatment to 150 minutes after treatment
measure: Gender differences in plasma oxytocin concentrations changes
timeFrame: Before and 30 minutes after treatment
measure: Gender differences in neural response to emotional faces stimuli
timeFrame: 45 minutes after treatment
measure: Gender differences in neural response to affective scenes stimuli
timeFrame: 45 minutes after treatment
measure: Gender differences in behavioral responses to emotional faces stimuli
timeFrame: 45 minutes after treatment
measure: Gender differences in behavioral responses to affective scenes stimuli
timeFrame: 45 minutes after treatment
measure: Interaction effect between gender and treatment on plasma oxytocin concentrations changes
timeFrame: Before and 30 minutes after treatment
measure: Interaction effect between gender and treatment on neural response to emotional faces stimuli
timeFrame: 45 minutes after treatment
measure: Interaction effect between gender and treatment on neural response to affective scenes stimuli
timeFrame: 45 minutes after treatment
measure: Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli
timeFrame: 45 minutes after treatment
measure: Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli
timeFrame: 45 minutes after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: school of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith M Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References: