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

University of Electronic Science and Technology of China

Status: Enrolling

Conditions: Healthy

Treatments: Drug: Intranasal placebo; Drug: Oral Oxytocin; Drug: Oral placebo; Drug: Intranasal Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05532501

UESTC-neuSCAN-91

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups, including a placebo group

Oral Oxytocin

Active Comparator group

Description:

Administer oxytocin (24 IU) orally

Treatment:

Drug: Oral Oxytocin

Intranasal Oxytocin

Active Comparator group

Description:

Administer oxytocin (24 IU) intranasally

Treatment:

Drug: Intranasal Oxytocin

Oral placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Oral placebo

Intranasal placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Intranasal placebo