Prognostic Markers of Post-Stroke Depression (PROMoSD)

Acute Ischemic Stroke Clinical Trial

— PROMoSD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580198
• Other study ID #: 20-6862
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: October 2022
• Source: Ruhr University of Bochum
• Contact: Daniel Richter, Dr,
• Phone: 00492345090
• Email: daniel.richter-c34[@]rub.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Diagnostic Test:
• Transcranial sonography.
Transcranial sonography examination to determine the brainstem raphe echogenicity.

Locations

Country	Name	City	State
Germany	St. Josef-Hospital Bochum	Bochum	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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