Major Depressive DisorderCLASS-BDNCT05480150
Chinese Longitudinal and Systematic Study of Bioplar Disorder
A study testing Escitalopram Oxalate Tablets, Quetiapine Fumarate Tablets and Lurasidone in people with Major Depressive Disorder and Bipolar Disorder, Mixed, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Affective disorders (mainly including major depressive disorder and bipolar disorder) are common, chronic and highly disabling mental disorders, which lack of objective biological markers. It is believed that genetic and environmental factors are involved in the development of affective disorders. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Mixed, Affective; Disorder, Organic
- What is being tested?
- Escitalopram Oxalate Tablets, Quetiapine Fumarate Tablets and Lurasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Both biological parents are Han nationality;
- Aged 16-65;
- The subjects met the clinical diagnostic criteria of DSM-5 for depressive episodes of MDD/BD;
- Did not take any immunomodulatory preparations within 1 month before enrollment;
- No clear history of respiratory tract, urinary system, digestive system infection within 1 month before enrollment;
Who cannot join
- Those with schizophrenia spectrum, neurodevelopmental disorder, dementia, memory impairment or other cognitive impairment that meet the DIAGNOSTIC criteria of DSM-5;
- Mental disorders caused by substance abuse (alcohol, drugs, etc.), patients suffering from serious physical diseases and immune system diseases, such as diabetes, thyroid diseases, hypertension, heart disease, liver and kidney dysfunction, autoimmune diseases, etc.;
- Had received medication (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
- those who had used ECT before enrollment;
- Currently have serious suicidal thoughts or behaviors, or serious excitement;
- those who cannot follow the doctor's advice or have no guardian;
Show all 9Show fewer
- pregnant or breast-feeding women, or those who plan to become pregnant;
- Contraindications to MRI examination;
- Other conditions that the researcher considers inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Hu ShaoHua, 13957162903, dorhushaohua@zju.edu.cn
About this study
Affective disorders (mainly including major depressive disorder and bipolar disorder) are common, chronic and highly disabling mental disorders, which lack of objective biological markers. It is believed that genetic and environmental factors are involved in the development of affective disorders. Gut microbes can affect the function of brain neural circuits by mediating metabolic, immune, endocrine and autonomic changes along the brain-gut axis. The brain can also regulate intestinal microbes through endocrine, neural structure, neurogenic exosomes and other pathways. Based on the brain-gut axis, this study intends to establish a large cohort of affective disorders, and screen out efficient and convenient biomarkers for clinical diagnosis and efficacy prediction by studying key indicators such as intestinal microbes, serum metabolites and immune indexes, brain-derived exosomes, and brain functional imaging.
Read the detailed description
Mental health is a major public health problem affecting the whole social and economic development. According to a 2019 report in The Lancet Psychiatry, the weighted lifetime prevalence of mental disorders (excluding dementia) in China is 16.6%, with the lifetime prevalence of emotional disorders as high as 7.4%.Affective disorders (mainly including depression and bipolar disorder) are common, chronic and highly disabling mental disorders.Back in 2008, the World Health Organization listed MDD（Major Depressive Disorder） as one of the three major contributors to the overall global burden of disease. It is expected that by 2030, the number of MDD patients will exceed the total number of cardiovascular disease patients combined and become the leading cause of disability in the world.
At present, the diagnostic criteria of mental disorders, including DSM-5 and ICD-11, still mainly rely on the evaluation of symptoms, lacking objective and intuitive biomarkers. Therefore psychiatrists are prone to disagreement in diagnosis and treatment of diseases, which is a realistic bottleneck hindering the development of psychiatry. The differential diagnosis of MDD and BD depressive episodes is an unavoidable clinical challenge, which often leads to misdiagnosis and affects the treatment and prognosis of the disease. Therefore, it is one of the important directions for the development of brain science to strengthen scientific research in the field of mental health, especially to explore the mechanism of disease occurrence and development, develop objective new auxiliary diagnostic technologies and innovate precise treatment strategies around major emotional disorders. It is believed that genetic and environmental factors are involved in the development of affective disorders. Gut microbes can affect the function of brain neural circuits by mediating metabolic, immune, endocrine and autonomic changes along the brain-gut axis. The brain can also regulate intestinal microbes through endocrine, neural structure, neurogenic exosomes and other pathways. This study based on brain - im axis, intends to create an emotional disorder large queue, through the study of gut microbes (diversity and abundance of species), serum metabolites, and immune index, brain outside source sex secretion, brain imaging and other key indicators, select high efficiency and convenient for clinical diagnosis and curative effect of prediction of biomarkers.
- Being tested
- Escitalopram Oxalate Tablets, Quetiapine Fumarate Tablets, Lurasidone
- Keywords
- Major Depressive Disorder, Bipolar Disorder, Affective Disorder, Gut-Brain Axis
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram Oxalate TabletsDrug
Also called Lexapro
Starting at 5mg qn, the treatment dose was titrated to 10-20mg qn within 1 week and maintained for 4 weeks
Quetiapine Fumarate TabletsDrug
Also called Seroquel
Starting at 50mg qn, the treatment dose was titrated to 300-400mg qn within 10 days, and maintained the treatment for 4 weeks.
LurasidoneDrug
Also called Latuda
Starting at 20mg qn, the treatment dose was titrated to 40mg qn within 6 days,and maintained the treatment for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| bipolar disorder | Experimental | Patients with BD depressive episode received standard treatment with quetiapine fumarate tablets, starting from 50mg/ night, titrated to a therapeutic dose of 300-400mg/ night within 10 days, and maintained treatment for 4 weeks. According to the patient's condition, patients with BD depressive episode could receive another standard treatment with lurasidone, starting from 20mg/ night, titrated to a therapeutic dose of 40mg/ night within 6 days, and maintained treatment for 4 weeks. Adverse reactions and changes in condition of all patients were recorded Receives: Drug: Quetiapine Fumarate Tablets; Drug: Lurasidone |
| major depressive disorder | Experimental | MDD depressive episode patients received standard treatment with escitalopram oxalate tablets, starting from 5mg/ day once, titrated to a therapeutic dose of 10-20mg/ day within 1 week, and maintained treatment for 4 weeks Receives: Drug: Escitalopram Oxalate Tablets |
| healthy control | No intervention | no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale(MADRS)
MADRS score is to evaluate the degree of depression, and the higher score means severer depression.
Measured: 0 ~16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480150
- Sponsor's protocol ID
- IIT20210291B-R1
- Acronym
- CLASS-BD
- Status last verified
- Oct 2022
- First submitted
- 28 Jul 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Arms and interventions can be shared, while the clinical data will not be shared
Publications
Tang A, Chen Y, Ding J, Li Z, Xu C, Hu S, Lai J. Gut microbiota remodeling and sensory-emotional functional disruption in adolescents with bipolar depression. J Transl Med. 2025 Oct 14;23(1):1083. doi: 10.1186/s12967-025-07152-4.
PubMed 41088296
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Longitudinal and Systematic Study of Bioplar Disorder
- ClinicalTrials.gov ID
- NCT05480150
- Acronym / sponsor ID
- CLASS-BD / IIT20210291B-R1
- Keywords
- Major Depressive Disorder, Bipolar Disorder, Affective Disorder, Gut-Brain Axis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2022 (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.
Affective disorders (mainly including major depressive disorder and bipolar disorder) are common, chronic and highly disabling mental disorders, which lack of objective biological markers. It is believed that genetic and environmental factors are involved in the development of affective disorders. Gut microbes can affect the function of brain neural circuits by mediating metabolic, immune, endocrine and autonomic changes along the brain-gut axis. The brain can also regulate intestinal microbes through endocrine, neural structure, neurogenic exosomes and other pathways. Based on the brain-gut axis, this study intends to establish a large cohort of affective disorders, and screen out efficient and convenient biomarkers for clinical diagnosis and efficacy prediction by studying key indicators such as intestinal microbes, serum metabolites and immune indexes, brain-derived exosomes, and brain functional imaging.
Detailed description
Mental health is a major public health problem affecting the whole social and economic development. According to a 2019 report in The Lancet Psychiatry, the weighted lifetime prevalence of mental disorders (excluding dementia) in China is 16.6%, with the lifetime prevalence of emotional disorders as high as 7.4%.Affective disorders (mainly including depression and bipolar disorder) are common, chronic and highly disabling mental disorders.Back in 2008, the World Health Organization listed MDD（Major Depressive Disorder） as one of the three major contributors to the overall global burden of disease. It is expected that by 2030, the number of MDD patients will exceed the total number of cardiovascular disease patients combined and become the leading cause of disability in the world.
At present, the diagnostic criteria of mental disorders, including DSM-5 and ICD-11, still mainly rely on the evaluation of symptoms, lacking objective and intuitive biomarkers. Therefore psychiatrists are prone to disagreement in diagnosis and treatment of diseases, which is a realistic bottleneck hindering the development of psychiatry. The differential diagnosis of MDD and BD depressive episodes is an unavoidable clinical challenge, which often leads to misdiagnosis and affects the treatment and prognosis of the disease. Therefore, it is one of the important directions for the development of brain science to strengthen scientific research in the field of mental health, especially to explore the mechanism of disease occurrence and development, develop objective new auxiliary diagnostic technologies and innovate precise treatment strategies around major emotional disorders. It is believed that genetic and environmental factors are involved in the development of affective disorders. Gut microbes can affect the function of brain neural circuits by mediating metabolic, immune, endocrine and autonomic changes along the brain-gut axis. The brain can also regulate intestinal microbes through endocrine, neural structure, neurogenic exosomes and other pathways. This study based on brain - im axis, intends to create an emotional disorder large queue, through the study of gut microbes (diversity and abundance of species), serum metabolites, and immune index, brain outside source sex secretion, brain imaging and other key indicators, select high efficiency and convenient for clinical diagnosis and curative effect of prediction of biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bipolar disorder | Experimental | Drug: Quetiapine Fumarate Tablets, Drug: LurasidonePatients with BD depressive episode received standard treatment with quetiapine fumarate tablets, starting from 50mg/ night, titrated to a therapeutic dose of 300-400mg/ night within 10 days, and maintained treatment for 4 weeks. According to the patient's condition, patients with BD depressive episode could receive another standard treatment with lurasidone, starting from 20mg/ night, titrated to a therapeutic dose of 40mg/ night within 6 days, and maintained treatment for 4 weeks. Adverse reactions and changes in condition of all patients were recorded |
| major depressive disorder | Experimental | Drug: Escitalopram Oxalate TabletsMDD depressive episode patients received standard treatment with escitalopram oxalate tablets, starting from 5mg/ day once, titrated to a therapeutic dose of 10-20mg/ day within 1 week, and maintained treatment for 4 weeks |
| healthy control | No intervention | –no interventions |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Both biological parents are Han nationality;
- Aged 16-65;
- The subjects met the clinical diagnostic criteria of DSM-5 for depressive episodes of MDD/BD;
- Did not take any immunomodulatory preparations within 1 month before enrollment;
- No clear history of respiratory tract, urinary system, digestive system infection within 1 month before enrollment;
Key exclusion criteria (9 listed)
- Those with schizophrenia spectrum, neurodevelopmental disorder, dementia, memory impairment or other cognitive impairment that meet the DIAGNOSTIC criteria of DSM-5;
- Mental disorders caused by substance abuse (alcohol, drugs, etc.), patients suffering from serious physical diseases and immune system diseases, such as diabetes, thyroid diseases, hypertension, heart disease, liver and kidney dysfunction, autoimmune diseases, etc.;
- Had received medication (such as antidepressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
- those who had used ECT before enrollment;
- Currently have serious suicidal thoughts or behaviors, or serious excitement;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram Oxalate TabletsAlso: LexaproStarting at 5mg qn, the treatment dose was titrated to 10-20mg qn within 1 week and maintained for 4 weeks | Drug | major depressive disorder |
| Quetiapine Fumarate TabletsAlso: SeroquelStarting at 50mg qn, the treatment dose was titrated to 300-400mg qn within 10 days, and maintained the treatment for 4 weeks. | Drug | bipolar disorder |
| LurasidoneAlso: LatudaStarting at 20mg qn, the treatment dose was titrated to 40mg qn within 6 days,and maintained the treatment for 4 weeks. | Drug | bipolar disorder |
Primary outcome
Montgomery-Asberg Depression Rating Scale(MADRS)
Time frame: 0 ~16 weeks
MADRS score is to evaluate the degree of depression, and the higher score means severer depression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 41088296Tang A, Chen Y, Ding J, Li Z, Xu C, Hu S, Lai J. Gut microbiota remodeling and sensory-emotional functional disruption in adolescents with bipolar depression. J Transl Med. 2025 Oct 14;23(1):1083. doi: 10.1186/s12967-025-07152-4.
- Individual participant dataSharing planned: No. Arms and interventions can be shared, while the clinical data will not be shared
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram Oxalate Tablets, Quetiapine Fumarate Tablets and Lurasidone in people with Major Depressive Disorder and Bipolar Disorder, Mixed, run by First Affiliated Hospital of Zhejiang University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Oct 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Hu (086-13957162903, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale(MADRS) (time frame: 0 ~16 weeks). 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 NCT05480150, which also lists 1 linked publication.
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 17 Oct 2022.