Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
- Conditions
- Healthy
- Interventions
- Drug: Placebo nasal spray
- Registration Number
- NCT03085654
- Lead Sponsor
- University of Electronic Science and Technology of China
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low anxiety group (single dose) Oxytocin nasal spray Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety. Low anxiety group (3 doses) Oxytocin nasal spray Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with low trait anxiety. Low anxiety group (5 doses) Oxytocin nasal spray Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety. High anxiety group (3 doses) Placebo nasal spray Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with high trait anxiety. High anxiety group (3 doses) Oxytocin nasal spray Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with high trait anxiety. High anxiety group (5 doses) Placebo nasal spray Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety. Low anxiety group (single dose) Placebo nasal spray Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety. High anxiety group (single dose) Oxytocin nasal spray Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety. Low anxiety group (5 doses) Placebo nasal spray Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety. High anxiety group (single dose) Placebo nasal spray Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety. High anxiety group (5 doses) Oxytocin nasal spray Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety. Low anxiety group (3 doses) Placebo nasal spray Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with low trait anxiety.
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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.
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.
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)
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
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
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)
Trial Locations
- Locations (1)
school of life science and technology, University of Electronic Science and Technology of China
🇨🇳Chengdu, Sichuan, China