The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes

NCT05532501 | Unknown

• 1 other identifier: UESTC-neuSCAN-91
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.

Conditions

Healthy

Keywords

Oral; Intranasal; Oxytocin; Emotional processing

Outcome Measures

Primary Outcomes (2)

• Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes.

  Comparison of whole brain neural (fMRI scanning) activation differences between oral and intranasal oxytocin administration to emotional scenes will be performed using a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and valence of emotional scenes (positive/negative/neutral) as within-subject factor, post-hoc comparisons will be conducted to further disentangle the significant interactions observed after the mixed ANOVA.

  45~70 minutes after treatment

• Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.

  Differences in behavioral ratings of valence (1-9 point Self-Assessmen-Manikin (SAM) scale, 1 means very negative, 9 means very positive, 5 means neutral), intensity (1-9 point SAM scale, 1 means mild, 9 means strong), and arousal (1-9 point SAM scale, 1 means not aroused at all, 9 means very aroused) of emotional scene stimuli between oral oxytocin and intranasal oxytocin groups will be examined using mixed ANOVAs, respectively.

  70~90 minutes after treatment

Secondary Outcomes (5)

• Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.

  45~70 minutes after treatment

• Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.

  45~90 minutes after treatment

• Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.

  45~90 minutes after treatment

• Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.

  45~70 minutes after treatment

• Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.

  0~70 minutes

Study Arms (4)

Oral Oxytocin

ACTIVE COMPARATOR

Administer oxytocin (24 IU) orally

Drug: Oral Oxytocin

Intranasal Oxytocin

ACTIVE COMPARATOR

Administer oxytocin (24 IU) intranasally

Drug: Intranasal Oxytocin

Oral placebo

PLACEBO COMPARATOR

Administer placebo orally (identical ingredients, except the active agent)

Drug: Oral placebo

Intranasal placebo

PLACEBO COMPARATOR

Administer placebo intranasally (identical ingredients, except the active agent)

Drug: Intranasal placebo

Interventions

Oral Oxytocin DRUG

Administer oxytocin (24 IU) orally, 6 individual 0.1 ml puffs (4 IU/0.1ml) on the tongue (lingual), one every 30 seconds

Also known as: Oxytocin orally

Oral Oxytocin

Intranasal Oxytocin DRUG

Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0.1ml), three puffs per nostril one every 30 seconds

Also known as: Oxytocin intranasally

Intranasal Oxytocin

Oral placebo DRUG

Administer placebo orally, 6 individual 0.1 ml puffs on the tongue (lingual), one every 30 seconds.

Also known as: Placebo orally

Oral placebo

Intranasal placebo DRUG

Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds

Also known as: Placebo intranasally

Intranasal placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• 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 2. Head trauma 3. Substance abuse 4. Medication

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

Interventions

Oxytocin

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: SPONSOR

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

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: September 20, 2022
• Primary Completion: December 20, 2022
• Study Completion: February 20, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-07

Locations

CN (1)