Construction and Clinical Validation Study of a Prediction Model for Depression After Ischemic Stroke

February 3, 2026 updated by: Min Su
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 Overview

Study Type

Observational

Enrollment (Estimated)

488

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Acute ischemic stroke patients who may develop post-stroke depression

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The group of PSD
The patient was diagnosed with PSD.
Group patients based on whether they have been diagnosed with PSD.
NPSD
The patient was not diagnosed with PSD.
Group patients based on whether they have been diagnosed with PSD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of post-stroke depression (PSD) that occurs 3 months after stroke
Time Frame: 3 months after stroke
3 months after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20251114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-stroke Depression

Clinical Trials on Group patients based on whether they have been diagnosed with PSD.

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