school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054, China
NCT Number: NCT03085654
To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.
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Notify Me18 year–30 year
Male
Interventional
Early Phase 1
Chengdu, Sichuan, 610054, China
In the present study, healthy male subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory (STAI). According to subjects' trait anxiety scores, they will be divided into high or low anxiety experimental groups.
Next, experiments will investigate the acute effect (single dose) and chronic effect (3 doses or 5 doses) of oxytocin on brain functional connectivity during resting-state and brain activation in response to watching emotional stimuli using functional magnetic resonance imaging (fMRI). Also the brain structure data (T1 and diffusion tensor imaging, DTI) of subjects will be collected. After finishing the scanning tasks, subjects will be required to rate the emotional valence, intensity and arousal of the pictures shown in the scanner.
During the course of the study subjects will complete a number of questionnaires: Empathy Quotient (EQ), Cheek and Buss Shyness scale (CBSS),Interpersonal Reactivity Index (IRI),Childhood Trauma Questionnaire (CTQ),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS),Positive and Negative Affect Schedule (PANAS),d2 attention test, and the Visual Analogue Scale for anxiety.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
Intranasal administration of oxytocin 24 international units per dose.
Other names: Oxytocin treatment
Intranasal administration of placebo 24 international units per dose.
Other names: Placebo control
Time frame: 5 days
Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days
Time frame: 5 days
Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days
Time frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute effects (single dose, day 1) and changes of effects with chronic treatment over the course of 5 days.
Time frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute effects (single dose, day 1) and changes of effects with chronic treatment over the course of 5 days.
Time frame: 5 days
Subjects will rate arousal of emotional stimuli using Likert Scales
Time frame: 5 days
Subjects will rate valence of emotional stimuli using Likert Scales
Time frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute (single dose, day 1) treatment effects and changes with chronic treatment (5 days)
Time frame: 5 days
The high and low trait anxiety groups will be compared with respect to differences in the acute (single dose, day 1) treatment effects and changes with chronic treatment (5 days)
University of Electronic Science and Technology of China
Other
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