Prognostic Markers of Post-Stroke Depression (PROMoSD)

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Diagnostic Test: Transcranial sonography.

• Registration Number: NCT05580198
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-13
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-17
• Primary Completion: 2022-11
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRH+	Transcranial sonography.	Acute ischemic stroke patients with brainstem raphe hypoechogenicity.
BRH-	Transcranial sonography.	Acute ischemic stroke patients without brainstem raphe hypoechogenicity.

Primary Outcome Measures

Name	Time	Method
Post-stroke depression	3 months	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

Secondary Outcome Measures

Name	Time	Method
Severity of depressive symptoms	3 months	Measured by the Hamilton Depression Rating Scale (HRSD, minimum score: 0, maximum score: 52), with higher scores indicating greater severity of depressive symptoms.

Trial Locations

Locations (1)

St. Josef-Hospital Bochum; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany