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Status unknownNCT05580198PROMoSDUpdated Oct 17, 2022

Prognostic Markers of Post-Stroke Depression (PROMoSD)

An observational study in Acute Ischemic Stroke, sponsored by Ruhr University of Bochum. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-17.

Sponsored by Ruhr University of Bochum · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute Ischemic Stroke
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 105 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who present with an acute ischemic stroke to the emergency department with the onset of symptoms within the past 14 days.

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

Exclusion Criteria:

  • Insufficient transtemporal bone window for transcranial sonography examination
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • BRH+

    Acute ischemic stroke patients with brainstem raphe hypoechogenicity.

    Diagnostic Test: Transcranial sonography.

  • BRH-

    Acute ischemic stroke patients without brainstem raphe hypoechogenicity.

    Diagnostic Test: Transcranial sonography.

Interventions

  • Diagnostic testTranscranial sonography.

    Transcranial sonography examination to determine the brainstem raphe echogenicity.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • St. Josef-Hospital Bochum
    Bochum, Nordrhein-Westfalen 44791, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05580198
Lead sponsor
Ruhr University of Bochum
Responsible party
Christos Krogias (Prof. Dr., Ruhr University of Bochum) — Principal investigator
First posted
Oct 14, 2022
Start date
Jan 1, 2021
Primary completion
Nov 2022 (estimated)
Completion
Mar 2023 (estimated)
Last update
Oct 17, 2022

Study contacts

Daniel Richter, Dr,
Contact
daniel.richter-c34@rub.de
00492345090
Christos Krogias, Prof.
principal investigator · St. Josef-Hospital Bochum, Ruhr-University Bochum

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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