Post Stroke Psychological Distress

Stroke Clinical Trial

— POSTPSYDIS  

Official title:

Depression and Posttraumatic Stress Disorder in Stroke Patients: an Observational Study of Neuro-psychiatric, Cognitive, and MR-Changes Over Time After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01187342
• Other study ID #: POSTPSYDIS
• Secondary ID: 4-026-08
• Status: Active, not recruiting
• Start date: October 2009
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Germany	Charité, Campus Benjamin Franklin, Dep. of Neurology	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurence of depression (GDS, SKID)	Geriatric Depression Scale, Structured Clinical interview for DSM-IV	90 days
Secondary	change in saliva cortisol	measurement of saliva cortisol levels	90days
Secondary	change in serumcholine	measurement of serumcholine	90days