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POSTPSYDIS: Post Stroke Psychological Distress

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01187342
Collaborator
German Federal Ministry of Education and Research (Other)
120
Enrollment
1
Location
147
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Depression and Posttraumatic Stress Disorder in Stroke Patients: an Observational Study of Neuro-psychiatric, Cognitive, and MR-Changes Over Time After Stroke
    Study Start Date :
    Oct 1, 2009
    Actual Primary Completion Date :
    Feb 1, 2017
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. occurence of depression (GDS, SKID) [90 days]

      Geriatric Depression Scale, Structured Clinical interview for DSM-IV

    Secondary Outcome Measures

    1. change in salivia cortisol [90days]

      measurement of salivia cortisol levels

    2. change in serumcholine [90days]

      measurement of serumcholine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité, Campus Benjamin Franklin, Dep. of Neurology Berlin Germany 12200

    Sponsors and Collaborators

    • Charite University, Berlin, Germany
    • German Federal Ministry of Education and Research

    Investigators

    • Study Director: Matthias Endres, MD, Center for Stroke Research Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthias Endres, Prof. MD, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01187342
    Other Study ID Numbers:
    • POSTPSYDIS
    • 4-026-08
    First Posted:
    Aug 24, 2010
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Matthias Endres, Prof. MD, Charite University, Berlin, Germany
    Stroke
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Nov 4, 2020