NCT03085654

Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: University of Electronic Science and Technology of China · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxytocin nasal spray	Intranasal administration of oxytocin 24 international units per dose.
DRUG	Placebo nasal spray	Intranasal administration of placebo 24 international units per dose.

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-03-31
• Completion: 2018-04-30
• First posted: 2017-03-21
• Last updated: 2018-10-29

Locations

1 site across 1 country: China