The Interaction Between Oxytocin and Serotonin

Study Overview
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Brief Summary
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the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)

Detailed Description
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Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

Official Title
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The Interaction Between Oxytocin and Serotonin on the Social-emotional Brain Networks

Conditions
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Healthy

Intervention / Treatment
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* Drug: oxytocin nasal spray
* Drug: intranasal placebo treatment (placebo-control for oxytocin)
* Drug: ATD treatment
* Drug: oral placebo treatment (placebo-control for ATD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: health subjects without past or current psychiatric or neurological disorders Right-handedness Exclusion Criteria: History of head injury; Medical or psychiatric illness. High blood pressure, general cardio-vascular alterations History of drug or alcohol abuse or addiction. Allergy against medications or general strong allergies Sleep disorders. Visual or motor impairments

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: male oxytocin and ATD group<br>male subjects receiving oxytocin and ATD treatment | Drug: oxytocin nasal spray<br>* intranasal administration of oxytocin (24 IU)<br>Drug: ATD treatment<br>* oral administration of ATD (75.2g) (Acute Tryptophan Depletion)<br>|
| Experimental: male oxytocin and placebo group<br>male subjects receiving oxytocin and ATD-placebo treatment | Drug: oxytocin nasal spray<br>* intranasal administration of oxytocin (24 IU)<br>Drug: oral placebo treatment (placebo-control for ATD)<br>* oral administration of a tryptophan-balanced mixture (78.2g)<br>|
| Experimental: male placebo and ATD group<br>male subjects receiving oxytocin placebo and ATD treatment | Drug: intranasal placebo treatment (placebo-control for oxytocin)<br>* intranasal administration of placebo nasal spray<br>Drug: ATD treatment<br>* oral administration of ATD (75.2g) (Acute Tryptophan Depletion)<br>|
| Placebo Comparator: male placebo group<br>male subjects receiving oxytocin placebo and ATD placebo treatment | Drug: intranasal placebo treatment (placebo-control for oxytocin)<br>* intranasal administration of placebo nasal spray<br>Drug: oral placebo treatment (placebo-control for ATD)<br>* oral administration of a tryptophan-balanced mixture (78.2g)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural processing during the emotion processing as assessed via fMRI | fMRI BOLD indices of neural processing in emotion related brain regions will be compared between the treatment groups | 6h after treatment | 
| Neural processing during the resting state as assessed via fMRI | Resting state activity in the emotional brain networks will be compared between the treatment groups | 6h after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, acute tryptophan depletion, emotion