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Post Stroke Psychological Distress (POSTPSYDIS)

This study is currently recruiting participants.
Verified April 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01187342
First received: July 1, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • occurence of depression (GDS, SKID) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in salivia cortisol [ Time Frame: 90days ] [ Designated as safety issue: No ]
  • change in serumcholine [ Time Frame: 90days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 CSB)
  More Information

No publications provided

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
Study First Received: July 1, 2010
Last Updated: April 23, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Stroke

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stroke
Cerebral Infarction
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 18, 2013