Post Stroke Psychological Distress (POSTPSYDIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01187342
Recruitment Status : Recruiting
First Posted : August 24, 2010
Last Update Posted : August 22, 2016
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany

July 1, 2010
August 24, 2010
August 22, 2016
October 2009
December 2016   (Final data collection date for primary outcome measure)
occurence of depression (GDS, SKID) [ Time Frame: 90 days ]
Depression (GDS, SKID) [ Time Frame: 90 days ]
Complete list of historical versions of study NCT01187342 on Archive Site
  • change in salivia cortisol [ Time Frame: 90days ]
  • change in serumcholine [ Time Frame: 90days ]
  • Morphological patterns [ Time Frame: 90days ]
  • laboratory test results [ Time Frame: 90days ]
  • cognitive and stress related parameters [ Time Frame: 90days ]
Not Provided
Not Provided
Post Stroke Psychological Distress
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.
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.
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Non-Probability Sample
Adult patients with acute ischemic stroke in MCA/AchA territory within 48 hours of onset
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  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact: Benjamin G Winter, MD Dr. med. 0049-30-8445 4102
Contact: Golo Kronenberg, MD Prof. Dr. 0049-30-450 560 317
4-026-08 ( Other Identifier: Ethics Committee Charité )
Not Provided
Not Provided
Matthias Endres, Charite University, Berlin, Germany
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Study Director: Matthias Endres, MD, Prof. Dr. med. Center for Stroke Research Berlin
Charite University, Berlin, Germany
August 2016