Post Stroke Psychological Distress (POSTPSYDIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 29, 2014
Last verified: July 2014

July 1, 2010
July 29, 2014
October 2009
May 2015   (final data collection date for primary outcome measure)
occurence of depression (GDS, SKID) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Depression (GDS, SKID) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01187342 on ClinicalTrials.gov Archive Site
  • change in salivia cortisol [ Time Frame: 90days ] [ Designated as safety issue: No ]
  • change in serumcholine [ Time Frame: 90days ] [ Designated as safety issue: No ]
  • Morphological patterns [ Time Frame: 90days ] [ Designated as safety issue: No ]
  • laboratory test results [ Time Frame: 90days ] [ Designated as safety issue: No ]
  • cognitive and stress related parameters [ Time Frame: 90days ] [ Designated as safety issue: No ]
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

Adult patients with acute ischemic stroke in MCA/AchA territory within 48 hours of onset

Stroke
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2015
May 2015   (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
Both
18 Years to 85 Years
No
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
Germany
 
NCT01187342
POSTPSYDIS, 4-026-08
No
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
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP