Post Stroke Psychological Distress (POSTPSYDIS)

Depression and Posttraumatic Stress Disorder in Stroke Patients: an Observational Study of Neuro-psychiatric, Cognitive, and MR-Changes Over Time After Stroke

Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke

Detailed Description

The study design relates to affective symptomatology, particularly poststroke depression and posttraumatic stress symptoms as well as to cognitive decline due to stress-related hypercortisolemia in the early phase after stroke. Extended MRI studies including a functional connectivity (fc-MRI) paradigm have been incorporated to study on subacute midbrain neurodegeneration as a possible morphological correlate of functional and clinical findings.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Charité, Campus Benjamin Franklin, Dep. of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with acute ischemic stroke in MCA/AchA territory within 48 hours of onset

Description

Inclusion Criteria:

• Stroke in MCA/AchA territory of striato-capsular (at least 125mm³) or non-striatal (10-100cm³) involvement
• MR-imaging can be conducted 24-48 hours of onset
• preserved communication skills

Exclusion Criteria:

• Patients with psychiatric conditions or medication in the last 4 weeks
• severe medical conditions
• limited prognosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-striatal lesion group; acute ischemic Stroke in MCA territory of 10-100 cm³ with sparing of striatocapsular structures
Striatal lesion group; acute ischemic stroke in MCA/AchA territory with involvement of at least 125 mm³ of striatocapsular structures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence of depression (GDS, SKID)	Geriatric Depression Scale, Structured Clinical interview for DSM-IV	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in serumcholine	measurement of serumcholine	90days
change in saliva cortisol	measurement of saliva cortisol levels	90days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Study Director: Matthias Endres, MD, Center for Stroke Research Berlin

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2017
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimated): August 24, 2010

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: POSTPSYDIS; 4-026-08 (Other Identifier: Ethics Committee Charité)