Prognostic Markers of Post-Stroke Depression (PROMoSD)

Study Overview
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Brief Summary
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Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke.

Detailed Description
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Post-stroke depression (PSD) is an important complication after a stroke. Despite significant limitations between studies of PSD risk factors, stroke severity or post-stroke disability, prior depressive episodes, and female sex are arguably the most well-known risk factors for developing PSD, although the predictive value of these factors is limited. A hypoechogenic brainstem raphe (BR) detected by transcranial sonography (TCS) is associated with depressive symptoms in distinct diseases but is also common with approximately 25% of the non-depressed population in Europe. The primary aim of this study is to investigate the association between BR hypoechogenicity and PSD occurrence in a prospective observational study design.

Official Title
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Prognostic Markers of Post-Stroke Depression: A Single-center Prospective Observational Study

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Diagnostic Test: Transcranial sonography.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke with the onset of symptoms within the past 14 days Diagnosis of AIS is confirmed by brain imaging, either computer tomography or magnetic resonance imaging Exclusion Criteria: Insufficient transtemporal bone window for transcranial sonography examination

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BRH+<br>Acute ischemic stroke patients with brainstem raphe hypoechogenicity. | Diagnostic Test: Transcranial sonography.<br>* Transcranial sonography examination to determine the brainstem raphe echogenicity.<br>|
| BRH-<br>Acute ischemic stroke patients without brainstem raphe hypoechogenicity. | Diagnostic Test: Transcranial sonography.<br>* Transcranial sonography examination to determine the brainstem raphe echogenicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-stroke depression | PSD diagnosis was defined according to the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V criteria) or by any new medication for anti-depressive indication during follow-up | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depressive symptoms | Measured by the Hamilton Depression Rating Scale (HRSD, minimum score: 0, maximum score: 52), with higher scores indicating greater severity of depressive symptoms. | 3 months |