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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oxytocin nasal spray
* Drug: Placebo nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion: healthy adult males Exclusion: past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High anxiety group (single dose)<br>Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety. | Drug: Oxytocin nasal spray<br>* Intranasal administration of oxytocin 24 international units per dose.<br>* Other names: Oxytocin treatment;Drug: Placebo nasal spray<br>* Intranasal administration of placebo 24 international units per dose.<br>* Other names: Placebo control;|
| Experimental: High anxiety group (3 doses)<br>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. | Drug: Oxytocin nasal spray<br>* Intranasal administration of oxytocin 24 international units per dose.<br>* Other names: Oxytocin treatment;Drug: Placebo nasal spray<br>* Intranasal administration of placebo 24 international units per dose.<br>* Other names: Placebo control;|
| Experimental: High anxiety group (5 doses)<br>Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety. | Drug: Oxytocin nasal spray<br>* Intranasal administration of oxytocin 24 international units per dose.<br>* Other names: Oxytocin treatment;Drug: Placebo nasal spray<br>* Intranasal administration of placebo 24 international units per dose.<br>* Other names: Placebo control;|
| Experimental: Low anxiety group (single dose)<br>Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety. | Drug: Oxytocin nasal spray<br>* Intranasal administration of oxytocin 24 international units per dose.<br>* Other names: Oxytocin treatment;Drug: Placebo nasal spray<br>* Intranasal administration of placebo 24 international units per dose.<br>* Other names: Placebo control;|
| Experimental: Low anxiety group (3 doses)<br>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. | Drug: Oxytocin nasal spray<br>* Intranasal administration of oxytocin 24 international units per dose.<br>* Other names: Oxytocin treatment;Drug: Placebo nasal spray<br>* Intranasal administration of placebo 24 international units per dose.<br>* Other names: Placebo control;|
| Experimental: Low anxiety group (5 doses)<br>Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety. | Drug: Oxytocin nasal spray<br>* Intranasal administration of oxytocin 24 international units per dose.<br>* Other names: Oxytocin treatment;Drug: Placebo nasal spray<br>* Intranasal administration of placebo 24 international units per dose.<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI | Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days | 5 days | 
| Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI | Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interaction of acute and chronic treatment effects with trait anxiety on neural activity | 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. | 5 days | 
| Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity | 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. | 5 days | 
| Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment) | Subjects will rate arousal of emotional stimuli using Likert Scales | 5 days | 
| Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment) | Subjects will rate valence of emotional stimuli using Likert Scales | 5 days | 
| Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment) | 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) | 5 days | 
| Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment) | 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) | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, trait anxiety, multiple doses