Clinical trial NCT03085654: Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
Official title: Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: multiple doses
oxytocin
trait anxiety
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 147
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion:

* healthy adult males

Exclusion:

* past or current psychiatric or neurological disorder
* head trauma
* substance abuse
* medication
* fMRI contraindications (e.g. metal implants)

Primary outcomes:
measure: Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI
timeFrame: 5 days
measure: Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI
timeFrame: 5 days
Secondary outcomes:
measure: Interaction of acute and chronic treatment effects with trait anxiety on neural activity
timeFrame: 5 days
measure: Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity
timeFrame: 5 days
measure: Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)
timeFrame: 5 days
measure: Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)
timeFrame: 5 days
measure: Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)
timeFrame: 5 days
measure: Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment)
timeFrame: 5 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: school of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kou J, Zhang Y, Zhou F, Gao Z, Yao S, Zhao W, Li H, Lei Y, Gao S, Kendrick KM, Becker B. Anxiolytic Effects of Chronic Intranasal Oxytocin on Neural Responses to Threat Are Dose-Frequency Dependent. Psychother Psychosom. 2022;91(4):253-264. doi: 10.1159/000521348. Epub 2022 Jan 27.