The Effects of Losartan on Emotion Processing

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of losartan (50mg, single dose) on salience processing

Detailed Description
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In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on salience processing in healthy participants will be examined. The study will adopt a previously validated visual Oddball fMRI paradigm, starting 90 minutes after subjects receive 50mg losartan or placebo. The task requires participants to respond to emotional and novelty oddballs. Neural activity will be assessed by the acquisition of functional magnetic resonance imaging (fMRI) data.

Official Title
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Losartan Effects on the Emotion Processing in Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: Losartan
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: history of head injury medical or psychiatric illness hypertension

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

Sexes Eligible for Study
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All

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: Losartan group<br> | Drug: Losartan<br>* administration of losartan (50 mg) (oral)<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo Oral Tablet<br>* administration of placebo (oral)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural activity as measured by BOLD fMRI during processing of emotional and novel stimuli | During the oddball paradigm a series of pictures will be presented in rapid succession. Some of the stimuli are oddballs, with respect to emotional content (highly threatening stimuli) or novelty (novel stimuli). Neural activity will be measured by functional magnetic resonance imaging (fMRI). The fMRI data will be examined using a Generalized Linear Model approach. The analysis will examine neural activity in terms of the blood oxygenation dependent (BOLD) response towards threatening and novel oddballs. Effects of treatment on the BOLD response towards threatening and novel oddballs will be examined by comparing the losartan- and placebo-treated subjects. | 105 to 145 minutes after treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural activity as measured by BOLD fMRI during processing of different categories of emotional and novel stimuli | The oddball paradigm will include different stimulus categories (animal pictures and human faces). Each category will include oddballs, with respect to emotional content (highly threatening stimuli) or novelty (novel stimuli). Neural activity will be measured by functional magnetic resonance imaging (fMRI). The fMRI data will be examined using a Generalized Linear Model approach. The analysis will examine neural activity differences between the stimulus categories (animal pictures, human face pictures) in terms of the blood oxygenation dependent (BOLD) response. Effects of treatment on the BOLD response towards different stimulus categories will be examined by comparing the losartan- and placebo-treated subjects. | 105 to 145 minutes after treatment administration | 
| Accuracy for target oddballs | Before the paradigm two stimuli will be designated as 'target' and subjects are required to respond by button press to this target. The accuracy for target detection will be computed. Effects of treatment will be examined by comparing the losartan- and placebo-treated subjects. | 105 to 145 minutes after treatment administration | 
| Reaction times for target oddballs | Before the paradigm two stimuli will be designated as 'target' and subjects are required to respond by button press to this target. The reaction times for correctly identified targets will be computed. Effects of treatment will be examined by comparing reaction times between the losartan- and placebo-treated subjects. | 105 to 145 minutes after treatment administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Losartan, emotion processing