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

NCT05073939 | Unknown

• 1 other identifier: UESTC-neuSCAN-84
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Oral Oxytocin; Emotional processing; Anxiety; Reward

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli

  Before treatment to 150 minutes after treatment

• The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli

  Before treatment to 150 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 plasma oxytocin concentrations changes

  Before and 30 minutes after treatment

Study Arms (2)

Oral Oxytocin

EXPERIMENTAL

Oxytocin orally (24 IU)

Drug: Oral Oxytocin

Oral Placebo

PLACEBO COMPARATOR

Placebo orally (identical ingredients, except the active agent)

Drug: Oral Placebo

Interventions

Oral Oxytocin DRUG

Administration of oxytocin (24 international units) orally

Also known as: Oxytocin Orally

Oral Oxytocin

Oral Placebo DRUG

Administration of placebo orally

Also known as: Placebo Orally

Oral Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects without any past or present psychiatric or neurological disorders

You may not qualify if:

• History of brain injury
• Head trauma
• Substance abuse
• Medication
• fMRI contraindications (e.g. metal implants)

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

school of life science and technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Keith M Kendrick, PhD

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith M Kendrick, PhD

CONTACT

86-28-61830811; k.kendrick.uestc@gmail.com

Weihua Zhao, PhD

CONTACT

86-28-61830811; zarazhao.uestc@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized placebo-controlled double-blind between-subject design

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 12, 2021
• Study Start: April 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: January 30, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

CN (1)