Clinical trial NCT05532501: The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes
Official title: Differential Modulation of Neural and Behavioral Responses to Emotional Scenes by Intranasal and Oral Oxytocin Administration in Healthy Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Oral
Intranasal
Oxytocin
Emotional processing
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled double-blind between-subject design
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes.
timeFrame: 45~70 minutes after treatment
measure: Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.
timeFrame: 70~90 minutes after treatment
Secondary outcomes:
measure: Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.
timeFrame: 45~70 minutes after treatment
measure: Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.
timeFrame: 45~90 minutes after treatment
measure: Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.
timeFrame: 45~90 minutes after treatment
measure: Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.
timeFrame: 45~70 minutes after treatment
measure: Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.
timeFrame: 0~70 minutes
Other outcomes:
Locations:
city: Chengdu
country: China
facility: school of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith M Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References: