Bipolar DisorderNCT03062332
The Gut Microbiota of Bipolar and Depression
An observational study of Bipolar Disorder and Major Depressive Disorder, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Background: The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. Investigators aim at elucidating the complement of the gut microbiome community for individuals with Major Depressive disorder (MDD) and Bipolar… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- Faecal genome
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2020to Nov 2022
- 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients are someone who are hospitalized in First Affiliated Hospital of Xi'an Jiaotong University. Healthy controls are healthy volunteers.
Who may be able to join
- Conforms to the diagnosis of bipolar disorder or major depressive disorder.
- Take antibiotics continuously less than 3 days in recent 3 months.
- 17.5≦BMI≦30
- Age≦65
Who cannot join
- who is diagnosed with physical diseases and other mental diseases.
- pregnant or lactational women
- who is diagnosed with mental retardation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiancang Ma
Xi'an, Shaanxi, 710061
Xiancang Ma, professor, +8613002951782, maxiancang@163.com
Wei Wang, doctor, 86-13991985805, xianwv@sina.com
About this study
Official title: Altered Fecal Microbiota Composition in Patients With Major Depressive Disorder and Bipolar Disorder
Background: The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. Investigators aim at elucidating the complement of the gut microbiome community for individuals with Major Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for relationships with symptoms.
Methods: Investigators prospect to recruit subjects including patients and controls amount to 240. All subjects will be collected for blood and stool samples,assessed by clinical scales. Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and clinical scales to obtain the possible interaction between diseases and gut microbiota.
Read the detailed description
Background: MDD (Major Depressive disorder) and BD (Bipolar disorder), whose specific pathogenesis is still unclear, are both a multi-factorial disease being caused by biological, psychological and social factors. Accumulating evidence suggests that gut microbiota play an important role in brain functions and in the pathogenesis of neuropsychiatric diseases, such as autism, anxiety, as well as depression. No study has thus far compared the human gut microbiota among BD, MDD and the healthy control (HC). The aim of this study is to compare the composition of fecal microbiota among BD, MDD and HC. Furthermore, investigators aim at identifying direct correlations between human fecal microbiota (as a proxy for gut microbiota) and symptoms.
Methods:
- Investigators aim at recruiting human subjects in total 240, which including mania episode of bipolar disorder (40), depressive episode of bipolar disorder (40), mixed episode of bipolar disorder (40), first episode of major depressive disorder (40), recurrent episode of major depressive disorder (40), and healthy control (40). All patients, diagnosed according to the research criteria of the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10）, come from The First Affiliated Hospital of Xi'an Jiaotong University and controls are healthy volunteers.
- Collecting blood and stool samples, evaluating clinical scales including Montgomery-Asberg Depression Scale (MADRS), Young Mania Rating Scale (YMRS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Measurement And Treatment Research To Improve Cognition In Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB), Clinical Global Impression (CGI) are all finished in first day after threshold.
- Measure the metabolon in blood such as S-CFA, and gut microbiota.
- Using Statistical Program for Social Sciences (SPSS) to compare general and clinical data among groups and analyze the correlation between the microbiota and symptoms.
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Being tested
- Faecal genome
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal genomeGenetic
Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar disorder,mania | The group includes subjects who are diagnosed to mania episode of bipolar disorder. Receives: Genetic: Faecal genome | |
| Bipolar disorder,depressive | The group includes subjects who are diagnosed to depression episode of bipolar disorder. Receives: Genetic: Faecal genome | |
| Bipolar disorder,mixed | The group includes subjects who are diagnosed to mixed episode of bipolar disorder. Receives: Genetic: Faecal genome | |
| First episode major depression | The group includes subjects who are diagnosed to first episode of major depression. Receives: Genetic: Faecal genome | |
| major depression，recurrent | The group includes subjects who are diagnosed to recurrent episode of major depression. Receives: Genetic: Faecal genome | |
| Healthy control | The group includes subjects who are Healthy control. Receives: Genetic: Faecal genome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the gut microbiota
The relative richness of the species, %
Measured: 3 months
Secondary outcomes (1)
metabolon
the concentration of short-chain fatty acid(S-CFA), μg/ml
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start16 Jan 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiancang Ma, professor, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062332
- Sponsor's protocol ID
- TGMOBAD2017
- Status last verified
- Aug 2021
- First submitted
- 16 Feb 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Fecal Microbiota Composition in Patients With Major Depressive Disorder and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03062332
- Acronym / sponsor ID
- TGMOBAD2017
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 23 Feb 2017 (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.
Background: The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. Investigators aim at elucidating the complement of the gut microbiome community for individuals with Major Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for relationships with symptoms.
Methods: Investigators prospect to recruit subjects including patients and controls amount to 240. All subjects will be collected for blood and stool samples,assessed by clinical scales. Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and clinical scales to obtain the possible interaction between diseases and gut microbiota.
Detailed description
Background: MDD (Major Depressive disorder) and BD (Bipolar disorder), whose specific pathogenesis is still unclear, are both a multi-factorial disease being caused by biological, psychological and social factors. Accumulating evidence suggests that gut microbiota play an important role in brain functions and in the pathogenesis of neuropsychiatric diseases, such as autism, anxiety, as well as depression. No study has thus far compared the human gut microbiota among BD, MDD and the healthy control (HC). The aim of this study is to compare the composition of fecal microbiota among BD, MDD and HC. Furthermore, investigators aim at identifying direct correlations between human fecal microbiota (as a proxy for gut microbiota) and symptoms.
Methods:
- Investigators aim at recruiting human subjects in total 240, which including mania episode of bipolar disorder (40), depressive episode of bipolar disorder (40), mixed episode of bipolar disorder (40), first episode of major depressive disorder (40), recurrent episode of major depressive disorder (40), and healthy control (40). All patients, diagnosed according to the research criteria of the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10）, come from The First Affiliated Hospital of Xi'an Jiaotong University and controls are healthy volunteers.
- Collecting blood and stool samples, evaluating clinical scales including Montgomery-Asberg Depression Scale (MADRS), Young Mania Rating Scale (YMRS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Measurement And Treatment Research To Improve Cognition In Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB), Clinical Global Impression (CGI) are all finished in first day after threshold.
- Measure the metabolon in blood such as S-CFA, and gut microbiota.
- Using Statistical Program for Social Sciences (SPSS) to compare general and clinical data among groups and analyze the correlation between the microbiota and symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder,mania | – | Genetic: Faecal genomeThe group includes subjects who are diagnosed to mania episode of bipolar disorder. |
| Bipolar disorder,depressive | – | Genetic: Faecal genomeThe group includes subjects who are diagnosed to depression episode of bipolar disorder. |
| Bipolar disorder,mixed | – | Genetic: Faecal genomeThe group includes subjects who are diagnosed to mixed episode of bipolar disorder. |
| First episode major depression | – | Genetic: Faecal genomeThe group includes subjects who are diagnosed to first episode of major depression. |
| major depression，recurrent | – | Genetic: Faecal genomeThe group includes subjects who are diagnosed to recurrent episode of major depression. |
| Healthy control | – | Genetic: Faecal genomeThe group includes subjects who are Healthy control. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are someone who are hospitalized in First Affiliated Hospital of Xi'an Jiaotong University. Healthy controls are healthy volunteers.
Key inclusion criteria (4 listed)
- Conforms to the diagnosis of bipolar disorder or major depressive disorder.
- Take antibiotics continuously less than 3 days in recent 3 months.
- 17.5≦BMI≦30
- Age≦65
Key exclusion criteria (3 listed)
- who is diagnosed with physical diseases and other mental diseases.
- pregnant or lactational women
- who is diagnosed with mental retardation.
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 |
|---|---|---|
| Faecal genomeSequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota. | Genetic | Bipolar disorder,depressive, Bipolar disorder,mania, Bipolar disorder,mixed, First episode major depression, Healthy control, major depression，recurrent |
Primary outcome
Composition of the gut microbiota
Time frame: 3 months
The relative richness of the species, %
1 secondary outcome
metabolon
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Xiancang Ma, professor study director
First Affiliated Hospital Xi'an Jiaotong University
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 Disorder and Major Depressive Disorder, run by First Affiliated Hospital Xi'an Jiaotong 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 4 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 19 Aug 2021. 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?
Contact Xiancang Ma, professor (13002951782, maxiancang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the gut microbiota (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2021; AzTrials last refreshed its copy on 26 Oct 2026.