An Exploratory Study on the Prediction of Recurrence Risk of Bipolar Disorder Using Sentiment Analysis Technology Based on Multi-modal Feature Fusion

May 1, 2026 updated by: Jun CHEN, Shanghai Mental Health Center
Bipolar disorder (BD) has become a significant public health problem with complex clinical manifestations, difficult treatment, and poor prognosis. However, there is still a lack of effective biological markers for diagnosing and predicting recurrence. Sentiment analysis computing usually refers to using machine equipment to classify, identify, interpret, and imitate human emotions. However, current multi-modal emotion analysis research is mainly based on one or two modalities. Due to the diversity and complexity of patients' emotional expressions, this single- and dual-modal information analysis is far from enough for accurate discrimination of emotional symptoms. Only emotion analysis technology based on multi-modal feature fusion can make more precise and effective judgments. The current project is based on our previous research on cognitive neuroimaging and big data analysis of bipolar disorder. The investigators plan to enroll 200 BD patients who meet DSM-5 diagnostic criteria and 200 healthy controls. The investigators will use sentiment analysis technology with multi-modal feature fusion (text data, audio and visual modalities, eye movements, and electrophysiology) to identify BD recurrence. Biological markers for risk prediction and an algorithm model for joint judgment of multi-source information will be established to analyze the characterization data. The effectiveness of this recurrence prediction model will be further verified and optimized through a large-sample, prospective cohort study design. It is hoped that it can provide a new method for predicting the recurrence risk of BD patients. In the near future, clinical decision-making aids based on this auxiliary method can be developed, and the translational application value of clinical diagnosis and treatment can be explored.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Mental Health Center
        • 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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

1. patients with bipolar disorder; 2. healthy controls.

Description

Patients group inclusion criteria:

  • Patients who have previously met or currently meet the diagnostic criteria for bipolar disorder according to DSM-5, whose condition and treatment are currently stable, and who cooperate with the assessment;
  • Age ≥18 years, <65 years;
  • Han Chinese ethnicity;
  • Sufficient visual and auditory abilities to complete the necessary examinations for the study;
  • Understanding the study content and signing the informed consent form. If the patient is unable to sign the informed consent form personally due to low education level or other reasons, it may be signed by a relative or guardian on their behalf.

exclusion criteria:

  • The presence of intellectual disability or other conditions that significantly affect the patient's current mental state;
  • the patient has a serious or unstable physical illness, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumors, immunodeficiency, and blood glucose levels higher than 12 mmol/L; or other diseases that may interfere with the test assessment (abnormal indicators more than twice the normal value).

Healthy controls group inclusion criteria:

  • Age ≥ 18 years, < 65 years;
  • Han Chinese ethnicity;
  • Gender matched to the patient group;
  • Sufficient visual and auditory ability to complete the necessary examinations for the study;
  • Understanding of the study content and signing of informed consent;
  • No family history of mental illness. exclusion criteria:
  • Individuals with a mental disorder conforming to DSM-5, or those with suspicious mental symptoms but not meeting the diagnostic criteria;
  • Individuals with severe physical illness that makes it difficult to complete the necessary examinations.

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
healthy control
Other: This is an observational study with no intervention.
This is an observational study with no intervention.
patients with bipolar disorder
Other: This is an observational study with no intervention.
This is an observational study with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recurrence status of patients with bipolar disorder
Time Frame: 1 year, patients will be followed-up every 3 months and healthy controls will be assessed only at baseline
The presence and the type of a relapse will be diagnosed by psychiatrists and assessed using DSM-5 by study assistants. Furthermore, predictive models for recurrence risk of bipolar disorder will be constructed, with adopting the Area Under Curve (AUC) of Receiver Operating Characteristic (ROC) and other measurements to evaluate the performance of constructed models.
1 year, patients will be followed-up every 3 months and healthy controls will be assessed only at baseline

Collaborators and Investigators

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

Sponsor

Shanghai Mental Health Center

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8247054596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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