Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

Study Overview
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Brief Summary
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The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.

Detailed Description
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In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to either receive intranasal Oxytocin (24IU, n= 30) or intranasal placebo (nasal spray administration without oxytocin, n = 30). Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min). Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape. Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment. Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Official Title
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Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

Conditions
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Healthy

Intervention / Treatment
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* Drug: intranasal Oxytocin(24IU)
* Drug: intranasal Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects without past or current psychiatric or neurological disorders Right-handedness Normal or corrected-normal version Exclusion Criteria: History of head injury Medical or psychiatric illness Hypertension General cardio-vascular alteration or diseases Allergy against medications Visual or motor impairments Claustrophobia Drug addiction Nicotine dependence FMRI contradictions

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo-controlled double-blind between-subject design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytoxin group<br>Drug: intranasal Oxytocin(24IU) | Drug: intranasal Oxytocin(24IU)<br>* Administration of intranasal Oxytocin(24IU)<br>|
| Placebo Comparator: Placebo group<br>Drug: intranasal Placebo | Drug: intranasal Placebo<br>* Administration of intranasal Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional connectivity during the resting state between brain systems involved in emotional processing. | 1.During the 8min resting state before and after the movie clips the intrinsic connectivity of the brain will be assessed. The intrinsic connectivity will be computed as temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. Effects of Oxytocin on the intrinsic architecture of the brain will be examined by comparing the Oxytocin- and Placebo- treated groups. | Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip). | Effects of treatment on dynamic functional connectivity during the fear clip watching phase will be examined by comparing dynamic functional connectivity indices between the Oxytoxin- and Placebo-treated group. | 80 minutes to 90 minutes after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytoxin, Fear, fMRI, Functional Connectivity