Depression-intervention study for optimization of reconvalesence after stroke

Depression-intervention study for optimization of reconvalesence after stroke - DISCOVER

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033792

Enrollment

Registered

2024-03-07

Start date

2024-03-05

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

I63.9 I61.9

Interventions

Group 1: Standard stroke care including standardized structured diagnostics, treatment of applicable risk factors and secondary prophylaxis, rehabilitation (if necessary) and outpatient treatment (gen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with acute ischemic or hemorrhagic stroke; Age = 18 years; Signed informed consent; signs of depression (Patient Health Questionnaire (PHQ)-9 = 10); acute neurological treatment in the University Hospital Augsburg

Exclusion criteria

Exclusion criteria: Transient ischaemic attack (TIA), Malignancy or other severe disease with life-expectancy less than the expected duration of the trial; Inability of giving informed consent (e.g. aphasia, dementia); Patients with legal representatives, Premorbid modified Rankin Scale (mRS) > 2

Design outcomes

Primary

Measure	Time frame
Changes of depressive symptoms assessed by PHQ-9 from baseline (V1) to day 84 (V2) after the index event.	—

Secondary

Measure	Time frame
Change in Patient Health Questionnaire-9 (PHQ-9) score from Baseline (V1) to days 84, 180 (V2, V3) and 365 (V4); Change in EuroQol- 5 Dimension (EQ-5D) score from Screening (V0) to days 84, 180 and 365 days (V2-V4); Change in modified Rankin Scale (mRS) from Screening (V0) to days 84, 180 and 365 (V2-V4); Return to work from Screening (V0) to days 84,180 and 365 days (V2-V4); Incidence of major cardiovascular events defined as nonfatal stroke (ischemic or hemorrhagic), nonfatal myocardial infarction (including acute coronary syndrome requiring emergency vascularisation), and vascular death (i.e. sudden cardiac death and death from acute myocardial infarction, ischemic or hemorrhagic stroke, heart failure, cardiovascular procedures, pulmonary embolism, or peripheral artery disease) within one year of the index event; Recurrent ischemic or hemorrhagic stroke or TIA (transient ischemic attack; defined as transient neurological deficit < 24 h and absence of DWI (Diffusion-weighted imaging) positive lesions on MRI (Magnetic resonance imaging)) within one year of the index-event; All-cause mortality at 14 months	—

Measure

Time frame

Change in Patient Health Questionnaire-9 (PHQ-9) score from Baseline (V1) to days 84, 180 (V2, V3) and 365 (V4); Change in EuroQol- 5 Dimension (EQ-5D) score from Screening (V0) to days 84, 180 and 365 days (V2-V4); Change in modified Rankin Scale (mRS) from Screening (V0) to days 84, 180 and 365 (V2-V4); Return to work from Screening (V0) to days 84,180 and 365 days (V2-V4); Incidence of major cardiovascular events defined as nonfatal stroke (ischemic or hemorrhagic), nonfatal myocardial infarction (including acute coronary syndrome requiring emergency vascularisation), and vascular death (i.e. sudden cardiac death and death from acute myocardial infarction, ischemic or hemorrhagic stroke, heart failure, cardiovascular procedures, pulmonary embolism, or peripheral artery disease) within one year of the index event; Recurrent ischemic or hemorrhagic stroke or TIA (transient ischemic attack; defined as transient neurological deficit < 24 h and absence of DWI (Diffusion-weighted imaging) positive lesions on MRI (Magnetic resonance imaging)) within one year of the index-event; All-cause mortality at 14 months

—

Countries

Germany

Contacts

Public ContactMichael Ertl

Universitätsklinikum Augsburg

michael.ertl@uk-augsburg.de+498214002991

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026