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

NCT ID: NCT05532501

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2023-02-20

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.

Detailed Description

Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli. However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes. In the current randomized, double-blind, between-subjects, placebo-controlled study, 160 healthy male subjects will be recruited and receive treatment either oxytocin (24IU, orally/intranasally) or placebo (orally/intranasally). Prior to treatment, all subjects will complete a number of questionnaires to control for potential group differences in potential confounders in terms of personality traits and mood, including: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), Interpersonal Reactivity Index (IRI). Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood. Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes). After fMRI scanning, subjects will be required to rate emotional stimuli presented during the scan on valence, intensity, and arousal using 1-9 point Self-Assessment Manikin (SAM) scales.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Oral Oxytocin

Administer oxytocin (24 IU) orally

Group Type: ACTIVE_COMPARATOR

Oral Oxytocin

Intervention Type: DRUG

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

Intranasal Oxytocin

Administer oxytocin (24 IU) intranasally

Group Type: ACTIVE_COMPARATOR

Intranasal Oxytocin

Intervention Type: DRUG

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

Oral placebo

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

Group Type: PLACEBO_COMPARATOR

Oral placebo

Intervention Type: DRUG

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

Intranasal placebo

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

Group Type: PLACEBO_COMPARATOR

Intranasal placebo

Intervention Type: DRUG

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

Interventions

Oral Oxytocin

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

Intervention Type: DRUG

Intranasal Oxytocin

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

Intervention Type: DRUG

Oral placebo

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

Intervention Type: DRUG

Intranasal placebo

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

Intervention Type: DRUG

Other Intervention Names

Oxytocin orally; Oxytocin intranasally; Placebo orally; Placebo intranasally

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 1. History of brain injury 2. Head trauma 3. Substance abuse 4. Medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith M Kendrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

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

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Keith M Kendrick, PhD

Role: CONTACT

k.kendrick.uestc@gmail.com

86-28-61830811

Weihua Zhao, PhD

Role: CONTACT

zarazhao.uestc@outlook.com

86-28-61830811

Facility Contacts

Weihua Zhao, PhD

Role: primary

Other Identifiers

UESTC-neuSCAN-91

Identifier Type: -

Identifier Source: org_study_id