- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05073939
Effect of Oral Oxytocin on Women's Response to Emotional Stimuli
October 19, 2021 updated by: Keith Kendrick, University of Electronic Science and Technology of China
Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- School of Life Science and Technology, University of Electronic Science and Technology of China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Oxytocin
Oxytocin orally (24 IU)
|
Administration of oxytocin (24 international units) orally
Other Names:
|
Placebo Comparator: Oral Placebo
Placebo orally (identical ingredients, except the active agent)
|
Administration of placebo orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before and 30 minutes after treatment
|
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.
|
45 minutes after treatment
|
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.
|
45 minutes after treatment
|
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.
|
45 minutes after treatment
|
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.
|
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
Time Frame: 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.
|
Before treatment to 150 minutes after treatment
|
The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli
Time Frame: 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.
|
Before treatment to 150 minutes after treatment
|
The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli
Time Frame: 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.
|
Before treatment to 150 minutes after treatment
|
The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli
Time Frame: 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.
|
Before treatment to 150 minutes after treatment
|
Gender differences in plasma oxytocin concentrations changes
Time Frame: 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.
|
Before and 30 minutes after treatment
|
Gender differences in neural response to emotional faces stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Gender differences in neural response to affective scenes stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Gender differences in behavioral responses to emotional faces stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Gender differences in behavioral responses to affective scenes stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Interaction effect between gender and treatment on plasma oxytocin concentrations changes
Time Frame: 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.
|
Before and 30 minutes after treatment
|
Interaction effect between gender and treatment on neural response to emotional faces stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Interaction effect between gender and treatment on neural response to affective scenes stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli
Time Frame: 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.
|
45 minutes after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
November 30, 2021
Study Completion (Anticipated)
January 30, 2022
Study Registration Dates
First Submitted
September 18, 2021
First Submitted That Met QC Criteria
October 11, 2021
First Posted (Actual)
October 12, 2021
Study Record Updates
Last Update Posted (Actual)
October 21, 2021
Last Update Submitted That Met QC Criteria
October 19, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-84
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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