Healthy
Conditions
Keywords
multiple doses, oxytocin, trait anxiety
Brief summary
To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.
Detailed description
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.
Interventions
DRUGOxytocin nasal spray
Intranasal administration of oxytocin 24 international units per dose.
DRUGPlacebo nasal spray
Intranasal administration of placebo 24 international units per dose.
Sponsors
University of Electronic Science and Technology of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * healthy adult males Exclusion: * past or current psychiatric or neurological disorder * head trauma * substance abuse * medication * fMRI contraindications (e.g. metal implants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI | 5 days | Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days |
| Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI | 5 days | Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity | 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. |
| Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment) | 5 days | Subjects will rate valence of emotional stimuli using Likert Scales |
| Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment) | 5 days | Subjects will rate arousal of emotional stimuli using Likert Scales |
| Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment) | 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) |
| Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment) | 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) |
| Interaction of acute and chronic treatment effects with trait anxiety on neural activity | 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. |
Countries
China
Outcome results
None listed