Bipolar Affective DisorderNCT05915312
Exosome for Early Diagnosis of Bipolar Affective Disorder
An observational study of Bipolar Affective Disorder and Major Depressive Disorder, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Affective Disorder, Major Depressive Disorder
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: descripted in the section of "Eligibility Criteria"
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Exosome, Early diagnosis, microRNA
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
accuracy of predicting diagnosis
the rate of patients got diagnosis indicated by biomarkers consistent with the diagnosis by DSM-5
Measured: 6.15.2023-6.30.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar Affective DisorderStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915312
- Sponsor's protocol ID
- 2022KJ264
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data but no the blood sample can be shared based on the resonable request.
Publications
Alonso J, Petukhova M, Vilagut G, Chatterji S, Heeringa S, Ustun TB, Alhamzawi AO, Viana MC, Angermeyer M, Bromet E, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Haro JM, Hinkov H, Hu CY, Karam EG, Kovess V, Levinson D, Medina-Mora ME, Nakamura Y, Ormel J, Posada-Villa J, Sagar R, Scott KM, Tsang A, Williams DR, Kessler RC. Days out of role due to common physical and mental conditions: results from the WHO World Mental Health surveys. Mol Psychiatry. 2011 Dec;16(12):1234-46. doi: 10.1038/mp.2010.101. Epub 2010 Oct 12.
PubMed 20938433Grande I, Goikolea JM, de Dios C, Gonzalez-Pinto A, Montes JM, Saiz-Ruiz J, Prieto E, Vieta E; PREBIS group. Occupational disability in bipolar disorder: analysis of predictors of being on severe disablement benefit (PREBIS study data). Acta Psychiatr Scand. 2013 May;127(5):403-11. doi: 10.1111/acps.12003. Epub 2012 Aug 23.
PubMed 22924855Drancourt N, Etain B, Lajnef M, Henry C, Raust A, Cochet B, Mathieu F, Gard S, Mbailara K, Zanouy L, Kahn JP, Cohen RF, Wajsbrot-Elgrabli O, Leboyer M, Scott J, Bellivier F. Duration of untreated bipolar disorder: missed opportunities on the long road to optimal treatment. Acta Psychiatr Scand. 2013 Feb;127(2):136-44. doi: 10.1111/j.1600-0447.2012.01917.x. Epub 2012 Aug 20.
PubMed 22901015
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Exosomes for Identifying Bipolar Affective Disorder in Early Stage
- ClinicalTrials.gov ID
- NCT05915312
- Acronym / sponsor ID
- 2022KJ264
- Keywords
- Exosome, Early diagnosis, microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jun 2023 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- descripted in the section of "Eligibility Criteria"
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 20938433Alonso J, Petukhova M, Vilagut G, Chatterji S, Heeringa S, Ustun TB, Alhamzawi AO, Viana MC, Angermeyer M, Bromet E, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Haro JM, Hinkov H, Hu CY, Karam EG, Kovess V, Levinson D, Medina-Mora ME, Nakamura Y, Ormel J, Posada-Villa J, Sagar R, Scott KM, Tsang A, Williams DR, Kessler RC. Days out of role due to common physical and mental conditions: results from the WHO World Mental Health surveys. Mol Psychiatry. 2011 Dec;16(12):1234-46. doi: 10.1038/mp.2010.101. Epub 2010 Oct 12.
- Background: PubMed 22924855Grande I, Goikolea JM, de Dios C, Gonzalez-Pinto A, Montes JM, Saiz-Ruiz J, Prieto E, Vieta E; PREBIS group. Occupational disability in bipolar disorder: analysis of predictors of being on severe disablement benefit (PREBIS study data). Acta Psychiatr Scand. 2013 May;127(5):403-11. doi: 10.1111/acps.12003. Epub 2012 Aug 23.
- Background: PubMed 22901015Drancourt N, Etain B, Lajnef M, Henry C, Raust A, Cochet B, Mathieu F, Gard S, Mbailara K, Zanouy L, Kahn JP, Cohen RF, Wajsbrot-Elgrabli O, Leboyer M, Scott J, Bellivier F. Duration of untreated bipolar disorder: missed opportunities on the long road to optimal treatment. Acta Psychiatr Scand. 2013 Feb;127(2):136-44. doi: 10.1111/j.1600-0447.2012.01917.x. Epub 2012 Aug 20.
- Individual participant dataSharing planned: Yes. the data but no the blood sample can be shared based on the resonable request.
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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. This study is not recruiting at the moment.
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 Bipolar Affective Disorder and Major Depressive Disorder, run by Tianjin Anding Hospital 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 0 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of predicting diagnosis (time frame: 6.15.2023-6.30.2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915312, which also lists 3 linked publications.
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 23 Jun 2023.