Depression-intervention study for optimization of reconvalesence after stroke

Not Applicable

Recruiting

Conditions: I63.9
I61.9
Cerebral infarction, unspecified
Intracerebral haemorrhage, unspecified

Registration Number: DRKS00033792

Lead Sponsor: niversitätsklinikum Augsburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

Patients with acute ischemic or hemorrhagic stroke; Age = 18 years; Signed informed consent; signs of depression (Patient Health Questionnaire (PHQ)-9 = 15)

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of depressive symptoms assessed by PHQ-9 from baseline (V1) to 90 (V3) and 365 (V5) days after the index event.

Secondary Outcome Measures

Name	Time	Method
Favorable functional outcome (mRS =2 and change in mRS) 90 and 365 days after the index event; Depressive symptoms during the study period assessed with the Montgomery–Åsberg Depression Rating Scale (MADRS); Quality of life (assessed by EuroQoL 5-Dimension (EQ-5D); Overall functioning (GAF) und psychiatric disease severity (CGI) during the study period; Incidence of major cardiovascular events defined as nonfatal stroke (ischemic or hemorrhagic), nonfatal myocardial infarction (including acute coronary syndrome requiring emergency vascularization), 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 and Transient ischemic attack within one year of the index-event; All-cause mortality at 12 months.