Prognostic Markers of Post-Stroke Depression (PROMoSD)

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05580198

Acronym

PROMoSD

Enrollment

105

Registered

2022-10-14

Start date

2021-01-01

Completion date

2023-03-31

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

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.

Interventions

DIAGNOSTIC_TESTTranscranial sonography.

Transcranial sonography examination to determine the brainstem raphe echogenicity.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Contacts

Primary ContactDaniel Richter, Dr,

daniel.richter-c34@rub.de00492345090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026