Oral Oxytocin Modulation of Responses to Emotional Stimuli

University of Electronic Science and Technology of China

Status: Unknown

Conditions: Healthy

Treatments: Drug: Oral Placebo; Drug: Oral Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT04320706

UESTC-neuSCAN-60

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: Male

Ages: 17 to 32 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Oral Oxytocin

Experimental group

Description:

Oxytocin orally (24 IU)

Treatment:

Drug: Oral Oxytocin

Oral Placebo

Placebo Comparator group

Description:

Placebo orally (identical ingredients, except the active agent)

Treatment:

Drug: Oral Placebo