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. Read our disclaimer for details. Identifier: NCT01187342
Recruitment Status : Active, not recruiting
First Posted : August 24, 2010
Last Update Posted : August 14, 2018
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany

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

Condition or disease

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
Estimated 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 : October 2009
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. occurence of depression (GDS, SKID) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. change in salivia cortisol [ Time Frame: 90days ]
    measurement of salivia cortisol levels

  2. change in serumcholine [ Time Frame: 90days ]
    measurement of serumcholine

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01187342

Charité, Campus Benjamin Franklin, Dep. of Neurology
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Study Director: Matthias Endres, MD Center for Stroke Research Berlin

Responsible Party: Matthias Endres, Prof. MD, Charite University, Berlin, Germany Identifier: NCT01187342     History of Changes
Other Study ID Numbers: POSTPSYDIS
4-026-08 ( Other Identifier: Ethics Committee Charité )
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Keywords provided by Matthias Endres, Charite University, Berlin, Germany:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases