Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

Study Overview
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Brief Summary
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The main aim of the study is to investigate the modulatory effects of intranasal oxytocin (24IU) on fear in naturalistic social and non-social contexts and the underlying neural mechanisms.

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 receive either intranasal oxytocin (24IU, n= 30) or placebo (n = 30) nasal spray. 45 minutes after treatment the participants will undergo a naturalistic fear induction paradigm during fMRI. During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips. Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear). 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 Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

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 |
| --- | --- | --- |
| BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) | BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) in response to four conditions of movie clips (Fear-Social\FS, Fear-Non-social\FNS, Neutral-Social\NS, Neutral-Non-social\NNS). Effects of Oxytocin on the neural basis of fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to fearful versus non fearful conditions. The investigators expect that Oxytocin will decrease reactivity in emotion reactive brain regions as compared to Placebo. | 45 minutes to 70 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experienced fear during the paradigm as assessed by self-reported ratings | Experienced fear during the paradigm as assessed by self-reported ratings on a 1-9 point Likert-scale ranging from 1 (no fear) to 9 (highest fear). Participants will rate their subjective level of fear following each video clip. Effects of Oxytocin on the level of subjective fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to the self-reported fear levels. The investigators expect that Oxytocin will decrease the level of subjective fear experience compared to Placebo. | 45 minutes to 70 minutes after treatment | 

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