NCT07294274

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Nov 2025Jul 2026

Study Start

First participant enrolled

November 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

November 27, 2025

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of post-stroke depression (PSD) that occurs 3 months after stroke

    3 months after stroke

Study Arms (2)

The group of PSD

The patient was diagnosed with PSD.

Diagnostic Test: Group patients based on whether they have been diagnosed with PSD.

NPSD

The patient was not diagnosed with PSD.

Diagnostic Test: Group patients based on whether they have been diagnosed with PSD.

Interventions

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

NPSDThe group of PSD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute ischemic stroke patients who may develop post-stroke depression

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 19, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations