Clinical trial NCT04320706: Oral Oxytocin Modulation of Responses to Emotional Stimuli
Official title: Oral Oxytocin Modulation of Brain and Behavioral Responses to Emotional Stimuli in Healthy Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: oral Oxytocin
emotional processing
anxiety
reward
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 80
Sex: MALE
Minimum age (years): 17
Maximum age (years): 32
Standard ages: CHILD
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 main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing.

Detailed description: A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. The investigators hypothesize that one method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the current double-blind, between-subject, placebo controlled study 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects will be required to complete both face emotion and emotional scene processing tasks during fMRI scanning. After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition. Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations. All subjects will be asked to complete a range of questionnaires before treatment to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), and Interpersonal Reactivity Index (IRI).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI
timeFrame: 45-90 minutes after treatment
measure: Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI
timeFrame: 45-90 minutes after treatment
measure: Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli
timeFrame: 45-115 minutes after treatment
measure: Change in blood oxytocin concentrations following oral administration of oxytocin
timeFrame: 30 minutes before treatment and 30 minutes after treatment
Secondary outcomes:
measure: Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings
timeFrame: 45-115 minutes after treatment
measure: Correlations between neural responses/functional connectivity in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin
timeFrame: 30 minutes before treatment to 90 minutes after treatment
measure: Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations
timeFrame: 30 minutes before treatment to 115 minutes after treatment
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 Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References: