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Post Stroke Psychological Distress (POSTPSYDIS)

This study is currently recruiting participants.
Verified August 2016 by Matthias Endres, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187342
First Posted: August 24, 2010
Last Update Posted: August 22, 2016
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.
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany
  Purpose
Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions.

Condition
Stroke

Study Type: Observational
Study Design: 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

Further study details as provided by Matthias Endres, Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • change in salivia cortisol [ Time Frame: 90days ]
  • change in serumcholine [ Time Frame: 90days ]

Biospecimen Retention:   Samples With DNA
Blood

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01187342


Contacts
Contact: Benjamin G Winter, MD Dr. med. 0049-30-8445 4102 benjamin.winter@charite.de
Contact: Golo Kronenberg, MD Prof. Dr. 0049-30-450 560 317 golo.kronenberg@charite.de

Locations
Germany
Charité, Campus Benjamin Franklin, Dep. of Neurology Recruiting
Berlin, Germany, 12200
Contact: Benjamin G Winter, MD, Dr. med.         
Contact: Golo Kronenberg, MD, Prof. Dr.         
Sub-Investigator: Winter G Benjamin, MD         
Sub-Investigator: Ulrike Lachmann, MD         
Sub-Investigator: Golo Kronenberg, MD, Prof. Dr.         
Principal Investigator: Matthias Endres, MD, Prof. Dr.         
Principal Investigator: Arno Villringer, MD, Prof. Dr.         
Sub-Investigator: C Rohr         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Study Director: Matthias Endres, MD, Prof. Dr. med. Center for Stroke Research Berlin
  More Information

Responsible Party: Matthias Endres, Prof. MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01187342     History of Changes
Other Study ID Numbers: POSTPSYDIS
4-026-08 ( Other Identifier: Ethics Committee Charité )
First Submitted: July 1, 2010
First Posted: August 24, 2010
Last Update Posted: August 22, 2016
Last Verified: August 2016

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

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