StrokePOSTPSYDISNCT01187342
Post Stroke Psychological Distress
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with acute ischemic stroke in MCA/AchA territory within 48 hours of onset
Who may be able to join
- 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
Who cannot join
- Patients with psychiatric conditions or medication in the last 4 weeks
- severe medical conditions
- limited prognosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité, Campus Benjamin Franklin, Dep. of Neurology
Berlin, State of Berlin, 12200
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of depression (GDS, SKID)
Geriatric Depression Scale, Structured Clinical interview for DSM-IV
Measured: 90 days
Secondary outcomes (2)
change in saliva cortisol
measurement of saliva cortisol levels
Measured: 90days
change in serumcholine
measurement of serumcholine
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Matthias Endres, Charite University, Berlin, Germany
- Investigators
- Matthias Endres, MD, Study director, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187342
- Sponsor's protocol ID
- POSTPSYDIS
- Other IDs
- 4-026-08
- Acronym
- POSTPSYDIS
- Status last verified
- Aug 2023
- First submitted
- 1 Jul 2010
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Kufner A, Rios AS, Winter B, Temuulen U, Khalil A, Grittner U, Schoner J, Akdeniz A, Lachmann U, Kronenberg G, Villringer A, Gertz K, Endres M. Neuropsychiatric changes following striatal stroke- results from the observational PostPsyDis study. Neurol Res Pract. 2025 May 12;7(1):32. doi: 10.1186/s42466-025-00390-3.
PubMed 40350509
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Posttraumatic Stress Disorder in Stroke Patients: an Observational Study of Neuro-psychiatric, Cognitive, and MR-Changes Over Time After Stroke
- ClinicalTrials.gov ID
- NCT01187342
- Acronym / sponsor ID
- POSTPSYDIS / POSTPSYDIS
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Oct 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acute ischemic stroke in MCA/AchA territory within 48 hours of onset
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with psychiatric conditions or medication in the last 4 weeks
- severe medical conditions
- limited prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurence of depression (GDS, SKID)
Time frame: 90 days
Geriatric Depression Scale, Structured Clinical interview for DSM-IV
2 secondary outcomes
change in saliva cortisol
Time frame: 90days
change in serumcholine
Time frame: 90days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 40350509Kufner A, Rios AS, Winter B, Temuulen U, Khalil A, Grittner U, Schoner J, Akdeniz A, Lachmann U, Kronenberg G, Villringer A, Gertz K, Endres M. Neuropsychiatric changes following striatal stroke- results from the observational PostPsyDis study. Neurol Res Pract. 2025 May 12;7(1):32. doi: 10.1186/s42466-025-00390-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Endres, MD study director
Center for Stroke Research Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence of depression (GDS, SKID) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.