Post-stroke DepressionNCT07294274
Construction and Clinical Validation Study of a Prediction Model for Depression After Ischemic Stroke
An observational study of Post-stroke Depression, run by Min Su at 1 site in China.
Trial summary
Post-stroke depression (PSD) is the most common neuropsychiatric disorder after a stroke, with an incidence rate of 20% to 60%. PSD is not only associated with higher mortality rates, poorer recovery, more obvious cognitive impairments, greater economic burdens, and lower quality of life, but also brings additional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Group patients based on whether they have been diagnosed with PSD.
- How many people
- 488 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 20 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute ischemic stroke patients who may develop post-stroke depression
Who may be able to join
- Patients with acute ischemic stroke;
- Admission within 7 days of symptom onset;
- The patient and/or the family members sign a written informed consent form.
Who cannot join
- Confusion of consciousness,severe cognitive impairment, etc
- Individuals with a history of depression, schizophrenia, bipolar disorder, etc;
- Individuals unable to participate in neuropsychological examinations due to hearing im pairments, lack of coordination, or neurological deficits, including se vere aphasia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Yanping Zhang, 86+15223049366, zhangyp8415@163.com
About this study
Post-stroke depression (PSD) is the most common neuropsychiatric disorder after a stroke, with an incidence rate of 20% to 60%. PSD is not only associated with higher mortality rates, poorer recovery, more obvious cognitive impairments, greater economic burdens, and lower quality of life, but also brings additional medical expenses and care pressure to families. Society also needs to bear higher medical costs. Currently, the early diagnosis of PSD is difficult, which may lead to poor prognosis after stroke. This study aims to utilize machine learning technology to integrate multi-dimensional indicators of patients with ischemic stroke, establish a risk prediction model for PSD, and assist in early, accurate, and individualized assessment of PSD risk in clinical practice.
- Conditions
- Post-stroke Depression
- Being tested
- Group patients based on whether they have been diagnosed with PSD.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group patients based on whether they have been diagnosed with PSD.Diagnostic test
Group patients based on whether they have been diagnosed with PSD.
| Study group | Role | What they receive |
|---|---|---|
| The group of PSD | The patient was diagnosed with PSD. Receives: Diagnostic Test: Group patients based on whether they have been diagnosed with PSD. | |
| NPSD | The patient was not diagnosed with PSD. Receives: Diagnostic Test: Group patients based on whether they have been diagnosed with PSD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of post-stroke depression (PSD) that occurs 3 months after stroke
Measured: 3 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Nov 2025
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Traditional Chinese Medicine Hospital
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294274
- Sponsor's protocol ID
- 20251114
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Clinical Validation Study of a Prediction Model for Depression After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07294274
- Acronym / sponsor ID
- 20251114
- Conditions
- Post-stroke Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Collaborators
- Chongqing Traditional Chinese Medicine Hospital
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- 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.
Post-stroke depression (PSD) is the most common neuropsychiatric disorder after a stroke, with an incidence rate of 20% to 60%. PSD is not only associated with higher mortality rates, poorer recovery, more obvious cognitive impairments, greater economic burdens, and lower quality of life, but also brings additional medical expenses and care pressure to families. Society also needs to bear higher medical costs. Currently, the early diagnosis of PSD is difficult, which may lead to poor prognosis after stroke. This study aims to utilize machine learning technology to integrate multi-dimensional indicators of patients with ischemic stroke, establish a risk prediction model for PSD, and assist in early, accurate, and individualized assessment of PSD risk in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group of PSD | – | Diagnostic Test: Group patients based on whether they have been diagnosed with PSD.The patient was diagnosed with PSD. |
| NPSD | – | Diagnostic Test: Group patients based on whether they have been diagnosed with PSD.The patient was not diagnosed with PSD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute ischemic stroke patients who may develop post-stroke depression
Key inclusion criteria (3 listed)
- Patients with acute ischemic stroke;
- Admission within 7 days of symptom onset;
- The patient and/or the family members sign a written informed consent form.
Key exclusion criteria (3 listed)
- Confusion of consciousness,severe cognitive impairment, etc
- Individuals with a history of depression, schizophrenia, bipolar disorder, etc;
- Individuals unable to participate in neuropsychological examinations due to hearing im pairments, lack of coordination, or neurological deficits, including se vere aphasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group patients based on whether they have been diagnosed with PSD.Group patients based on whether they have been diagnosed with PSD. | Diagnostic test | NPSD, The group of PSD |
Primary outcome
The number of post-stroke depression (PSD) that occurs 3 months after stroke
Time frame: 3 months after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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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.
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 Post-stroke Depression, run by Min Su at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanping Zhang (86+15223049366, zhangyp8415@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of post-stroke depression (PSD) that occurs 3 months after stroke (time frame: 3 months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.