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

Sponsor
University of Electronic Science and Technology of China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05073939
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Oral Oxytocin
  • Drug: Oral Placebo
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized placebo-controlled double-blind between-subject designRandomized placebo-controlled double-blind between-subject design
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Oral Oxytocin

Oxytocin orally (24 IU)

Drug: Oral Oxytocin
Administration of oxytocin (24 international units) orally
Other Names:
  • Oxytocin Orally
  • Placebo Comparator: Oral Placebo

    Placebo orally (identical ingredients, except the active agent)

    Drug: Oral Placebo
    Administration of placebo orally
    Other Names:
  • Placebo Orally
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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.

    12. 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.

    13. 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.

    14. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1school of life science and technology, University of Electronic Science and Technology of ChinaChengduSichuanChina611731

    Sponsors and Collaborators

    • University of Electronic Science and Technology of China

    Investigators

    • Principal Investigator: Keith M Kendrick, PhD, University of Electronic Science and Technology of China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keith Kendrick, Principal Investigator, University of Electronic Science and Technology of China
    ClinicalTrials.gov Identifier:
    NCT05073939
    Other Study ID Numbers:
    • UESTC-neuSCAN-84
    First Posted:
    Oct 12, 2021
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Keith Kendrick, Principal Investigator, University of Electronic Science and Technology of China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021