Exosome for Early Diagnosis of Bipolar Affective Disorder

June 13, 2023 updated by: Tianjin Anding Hospital

Study on Exosomes for Identifying Bipolar Affective Disorder in Early Stage

Objectives: Bipolar disorder (BD) is a chronic and recurrent mental illness characterized by depressive episodes and manic or hypomanic episodes, leading to severe functional impairment and cognitive damage. Unfortunately, it is difficult to accurately distinguish between major depressive disorder (MDD) and BD in the early stages, resulting in misdiagnosis and mistreatment. According to statistics, only 20% of BD patients with initial depressive symptoms receive a correct diagnosis within the first year of onset, with an average delay of 5-10 years from onset to final diagnosis. BD patients are often treated with antidepressant medication systematically due to being diagnosed with MDD, affecting the disease course and clinical outcomes. The current study aims to explore the role of peripheral exosomes as biomarker to distinguish BD from MDD in early stage.

Methods: The study includes two stages: the first stage is a case-control study, comparing the concentrations of peripheral blood exosome metabolites (microRNA and related proteins) among three groups (BD patients, MDD patients, and healthy controls, n=30 per group) to identify target microRNA and proteins with statistically significant differences. The "latent class analysis (LCA)" on target microRNA and protein will be performed on all samples to observe whether it can effectively distinguish bipolar disorder, depressive episode, and healthy participants. Then, based on the LCA analysis results, "receiver operating characteristic (ROC)" analysis will be conducted to further determine the optimal concentration cut-off value for each indicator and ultimately determine the target biomarkers. The second stage is a clinical validation study in which subjects, who come from an on-going trial and initiated with a depressive episode and were followed up for five years at least, are divided into two groups (MDD group and BD group, n=20 respectively) based on whether they have hypomanic/manic episodes currently or previously, according to the DSM-5 diagnosed with SCID-5. All target biomarkers will be test in peripheral blood samples reserved at the initial stage to detect whether the diagnosis indicated by the biomarkers is consistent with diagnosis by DSM-5. As well as the accuracy of predicting diagnosis, the correlation between specific biomarkers and treatment response, clinical outcome, and adverse reactions will also be observed.

Discussion: It is difficult to explore central nervous system diseases through the peripheral system in the context of the blood-brain barrier. However, exosomes can freely pass through the blood-brain barrier and serve as a good medium for connecting the peripheral system and the central nervous system. This study aims to explore plasma exosome microRNAs and related proteins as biological markers for early diagnosis of bipolar disorder, for example, which microRNAs or proteins are presented in the BD patient group, or what concentrations of microRNAs or proteins are significantly different between the BD patients and MDD patients. Improving the early diagnosis of BD would help develop appropriate clinical intervention strategy, improve the quality of disease management, and significantly reduce the burden of disease. At the same time, this study is also hope to provide a theoretical basis for exploring the pathogenesis of bipolar disorder.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

130

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

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

descripted in the section of "Eligibility Criteria"

Description

Bipolar disorder group:

Inclusion criteria: ① Meets the diagnostic criteria for bipolar disorder in DSM-5; ② Han ethnicity, any gender, aged 18-60 years old; ③ Initial symptoms were depressive episodes.

Exclusion criteria: ① Meets the diagnostic criteria for other mental disorders in DSM-5; ② Accompanied by severe physical illnesses, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, pulmonary diseases, thyroid diseases, diabetes, epilepsy, metabolic syndrome, etc.; ③ History of alcohol abuse or use of other psychoactive substances; ④ Pregnant or lactating women; ⑤ Any factors that hinder the participant from providing informed consent or participating in the study.

Major depressive disorder group:

Inclusion criteria: ① Meets the diagnostic criteria for depressive episodes in DSM-5; ② Han ethnicity, any gender, aged 18-60 years old; ③ A history of illness of no less than 5 years.

Exclusion criteria: Same as bipolar disorder group.

Healthy control group:

Inclusion criteria: ① No mental disorders that meet the diagnostic criteria in DSM-5; ② Han ethnicity, any gender, aged 18-60 years old.

Exclusion criteria: ① Any mental disorders that meet the diagnostic criteria in DSM-5 within two generations of the family; ② Accompanied by severe physical illnesses, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, pulmonary diseases, thyroid diseases, diabetes, epilepsy, metabolic syndrome, etc.; ③ History of alcohol abuse or use of other psychoactive substances; ④ Pregnant or lactating women; ⑤ Any factors that hinder the participant from providing informed consent or participating in the study.

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
BD group
patients with bipolar disorder for the first stage
MDD group
patients with major depressive disorder for the first stage
healthy control
participants without psychosis for the first stage
BD group II
patients with bipolar disorder for the second stage
MDD group II
patients with bipolar disorder for the second stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of predicting diagnosis
Time Frame: 6.15.2023-6.30.2024
the rate of patients got diagnosis indicated by biomarkers consistent with the diagnosis by DSM-5
6.15.2023-6.30.2024

Collaborators and Investigators

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

Sponsor

Tianjin Anding Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 15, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022KJ264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the data but no the blood sample can be shared based on the resonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

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