Bipolar DisorderNCT04024553
A Genetic Family Cohort Study of Bipolar Disorder in Chinese Han Population
An observational study of Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study intends to find out the pathogenic genes of bipolar disorder by collecting the two-phase family of Chinese Han population with the large sample using a family cohort study design, combined with the new generation of high-throughput sequencing technology and Genome-Wide Association Studies (GWAS)… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- Type of treatment
- Injection or infusion
- How many people
- 2,520 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2019to 31 Dec 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We intend to expand the sample size of the family, and collect 50 core families and 200 healthy controls at this stage. Similarly, during the validation phase, it is proposed to include 30 core families for verification. To verify the results of the first part of the study in sporadic BD patients and healthy controls, 783 patients with sporadic BD and 692 healthy controls were calculated by sample size estimation formula. With drop-off rate of 20%, 939 cases and 830 cases are needed respectively. In order to avoid other factors falling off, it is proposed to include 1000 cases of sporadic BD patients and healthy controls respectively.
Who may be able to join
- BD patients from BD family:
- Meets the diagnostic criteria of BD in DSM-IV-TR, does not limit subtypes and current disease status;
- age ≥ 15 years old;
- Han nationality;
- There are enough audition levels to complete the necessary examinations for the study;
- Understand the research content and sign the informed consent form. If the patient is unable to sign the informed consent form due to the young age, senior age, low education level or other reasons, they can be signed by their relatives or signed by their guardian.
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- Healthy menbers from BD family:
- age ≥ 15 years old;
- Han nationality;
- biological parents or compatriots of the proband, cousins;
- There are enough audition levels to complete the necessary examinations for the study;
- Understand the research content and sign the informed consent form. If the patient is unable to sign the informed consent form due to the young age, senior age, low education level or other reasons, they can be signed by their relatives or signed by their guardian.
- Healthy control enrollment criteria without family history:
- age ≥ 15 years old;
- Han nationality;
- gender matches the patient group in the family;
- There are enough audition levels to complete the necessary examinations for the study;
- Understand the research content and sign the informed consent form. If the patient is unable to sign the informed consent form due to his or her age, advanced age, low education level or other reasons, he or she may be entrusted to sign by his or her relatives or signed by his guardian;
Who cannot join
- BD patients from BD family:
- There is a DSM-IV-TR axis II disease (mental retardation, etc.) that significantly affects the patient's current state of mind;
- There are serious physical diseases, it is difficult to complete the necessary examinations, including history of brain trauma or cerebrovascular disease, severe cirrhosis, acute and chronic failure, severe diabetes, aplastic anemia, moderate to severe malnutrition and other serious nerves, heart, Physical diseases such as liver, kidney, endocrine, and blood system or diseases that may interfere with the test evaluation (the abnormal index is more than 2 times higher than the normal value).
- Healthy menbers from BD family and healthy control enrollment criteria without family history::
- with a mental disorder that meets the diagnostic criteria for DSM-IV-TR axis I or who have suspected psychosis but do not meet the diagnostic criteria;
- There are DSM-IV-TR axis II diseases (mental retardation, etc.) that significantly affect the patient's current mental state;
- There are serious physical illnesses, and it is difficult to complete the necessary examinations.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
This study intends to find out the pathogenic genes of bipolar disorder by collecting the two-phase family of Chinese Han population with the large sample using a family cohort study design, combined with the new generation of high-throughput sequencing technology and Genome-Wide Association Studies (GWAS), Proteomics, bioinformatics analysis, etc., which is expected to be clarified at the genetic level. The pathogenesis of bipolar disorder. At the same time, the investigators will conduct a five-year follow-up of cognitive function, brain function imaging and other major clinical symptoms in patients with bipolar disorder in the core family, and to explore familial bipolar disorder and sporadic biphasic. Differences in the clinical features of the disorder, in order to explore sensitive and specific biomarkers from a multidimensional perspective (cognitive function, brain imaging, genetic features, clinical features, etc.), which may contribute to bipolar disorder in the future. Accurate diagnosis and early identification and prevention have important scientific significance and clinical diagnosis and treatment significance.
Read the detailed description
Bipolar disorder (BD) is a serious, complex, family-grafting mental illness. Studies have shown that genetic factors may be the dominant factor in the pathogenesis of bipolar disorder, thus, it is worth looking forward to getting started and clarifying the etiology of bipolar disorder from a genetic perspective. However, earlier genetic studies such as linkage analysis, genetic mutation detection (preferred candidate genes), and recent genetic studies (no need to presuppose candidate genes) such as Whole Genome Sequencing (WGS), whole genome GWAS and Whole-exome sequencing (WES) failed to identify any biogenic disorder gene or chromosomal region that plays a major role in, which may be related to the synergy of population heterogeneity, insufficient sample size or coordination effect caused by common mutations.
As a familial, highly heritable psychiatric disease, the literature suggests that the pathogenic genes of bipolar disorder may be directly derived from the intergenerational transmission of rare mutations in family members, and these rare variants are more likely to be predicated from the family. It has been found that the family has a higher frequency and is more susceptible to detecting susceptibility genes for bipolar disorder. Therefore, the family research design combined with WGS, GWAS and other advanced genetic research methods can reduce the unnecessary sample size, eliminate the confounding factors of the population, and more easily capture the potential genes of bipolar disorder.
However, at present, there are few reports of foreign bipolar disorder family and the results are not consistent. There is no research report on the large sample family of Chinese Han population in China. Therefore, it is necessary to expand the family sample size and combine with new genetic research methods in the Han population. explore. Therefore, this study intends to find out the pathogenic genes of bipolar disorder by collecting the two-phase family of Chinese Han population with the large sample using a family cohort study design, combined with the new generation of high-throughput sequencing technology and GWAS, Proteomics, bioinformatics analysis, etc., which is expected to be clarified at the genetic level. The pathogenesis of bipolar disorder. At the same time, the investigators will conduct a five-year follow-up of cognitive function, brain function imaging and other major clinical symptoms in patients with bipolar disorder in the core family, and to explore familial bipolar disorder and sporadic biphasic. Differences in the clinical features of the disorder, in order to explore sensitive and specific biomarkers from a multidimensional perspective (cognitive function, brain imaging, genetic features, clinical features, etc.), which may contribute to bipolar disorder in the future. Accurate diagnosis and early identification and prevention have important scientific significance and clinical diagnosis and treatment significance.
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, family, genetic
- Medical subject headings
- Bipolar Disorder
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 |
|---|---|---|
| bipolar disorder family | Screening priori BD-I/BD-II patients， their relatives with mental illness (including but not limited to BD) and their healthy families. | |
| health control | Group-matched non-psychiatric family history health subjects were enrolled, DSM-IV-TR is used for demographic assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential risk genes
The investigators will collect peripheral blood samples of patients and healthy controls during the baseline period, and blood samples from family members during follow-up period. The blood will be used for WGS, GWAS, WES to get candidate genes. Reported high risk genes such as CACNA1C、DTNA、FOXP1 and so on are the focus.
Measured: at december 2022
Secondary outcomes (9)
HAMD-17 scores of patients and high-risk subjects
Hamilton depression scale is used to assess subjects at the baseline and every follow-up point(health controls are assessed only at baseline). HAMD is the most commonly used scale for clinically assessed depression. Total score < 7 points means normal; total scores in 7~17 points indicates that there may be depression; total scores in 17~24 points shows that there must be depression; total score >24 points means major depression.
Measured: by december 2022
Onset age of BD subjects
Data of onset age will be record since the subjects join this peoject, and the invetigators will continue recording especially at each follow-up point.
Measured: by december 2022
Wisconsin Card Sorting Test results
The family members will be tested at baseline and 5 follow-up periods, totally 6 times. The healthy control will be tested once at baseline. Wisconsin Card Sorting Test (WCST) reflects congnitive function, which includes 13 indexes. Higher scores indicate better congnition.
Measured: by december 2022
Characteristic changes of electroencephalogram
In this study the investigators use EEG equipment from BrainProducts of Germany. The sampling frequency is 1000hz. Detection items include gamma resonance, mismatched negative wave MMN, auditory event related potential P300, visual event related potential P300, and resting EEG. Family members were tested for the baseline period and subsequent annual follow-up period, a total of 6 times. Healthy controls test once at the baseline period.
Measured: by december 2022
YMRS scores of patients and high-risk subjects
Young's Mania Rating Scale is used to assess subjects at the baseline and every follow-up point(health controls are assessed only at baseline). It is mainly used to assess the symptoms and severity of mania, which includes 11 items. Total scores range from 0 to 60, higher scores means the symptoms are more severe.
Measured: by december 2022
Course of disease of BD subjects
Disease course will be record since the subjects join this peoject, and until the end of this study.
Measured: by december 2022
Treatment plan of BD subjects
Treatment of BD patients will be record since the subjects join this peoject, and the invetigators will continue recording especially at each follow-up point.
Measured: by december 2022
STROOP test results
The family members will be tested at baseline and 5 follow-up periods, totally 6 times. The healthy control will be tested once at baseline. STROOP test is a Cognitive psychology test, which is also called color word conflict test. In the randomly appearing text combinations, subjects are supposed to quickly read out names of colors according to the color of the text, and then the reading time is compared in this study.
Measured: by december 2022
Repetitive Neuropsychological Status test (RBANS) results
The family members will be tested at baseline and 5 follow-up periods, totally 6 times. The healthy control will be tested once at baseline. RBANS is a test for subjects' neuropsychological state. It has 12 tasks. The original score will be converted to a standard score with a total score of 100 points. Higher scores means better congnitive function.
Measured: by december 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start28 Mar 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 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
- 2,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiru Fang, Principal investigator, Shanghai Mentao Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024553
- Sponsor's protocol ID
- CRC2018ZD02
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genetic Family Cohort Study of Bipolar Disorder in Chinese Han Population
- ClinicalTrials.gov ID
- NCT04024553
- Acronym / sponsor ID
- CRC2018ZD02
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, family, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,520 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jul 2019 (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.
This study intends to find out the pathogenic genes of bipolar disorder by collecting the two-phase family of Chinese Han population with the large sample using a family cohort study design, combined with the new generation of high-throughput sequencing technology and Genome-Wide Association Studies (GWAS), Proteomics, bioinformatics analysis, etc., which is expected to be clarified at the genetic level. The pathogenesis of bipolar disorder. At the same time, the investigators will conduct a five-year follow-up of cognitive function, brain function imaging and other major clinical symptoms in patients with bipolar disorder in the core family, and to explore familial bipolar disorder and sporadic biphasic. Differences in the clinical features of the disorder, in order to explore sensitive and specific biomarkers from a multidimensional perspective (cognitive function, brain imaging, genetic features, clinical features, etc.), which may contribute to bipolar disorder in the future. Accurate diagnosis and early identification and prevention have important scientific significance and clinical diagnosis and treatment significance.
Detailed description
Bipolar disorder (BD) is a serious, complex, family-grafting mental illness. Studies have shown that genetic factors may be the dominant factor in the pathogenesis of bipolar disorder, thus, it is worth looking forward to getting started and clarifying the etiology of bipolar disorder from a genetic perspective. However, earlier genetic studies such as linkage analysis, genetic mutation detection (preferred candidate genes), and recent genetic studies (no need to presuppose candidate genes) such as Whole Genome Sequencing (WGS), whole genome GWAS and Whole-exome sequencing (WES) failed to identify any biogenic disorder gene or chromosomal region that plays a major role in, which may be related to the synergy of population heterogeneity, insufficient sample size or coordination effect caused by common mutations.
As a familial, highly heritable psychiatric disease, the literature suggests that the pathogenic genes of bipolar disorder may be directly derived from the intergenerational transmission of rare mutations in family members, and these rare variants are more likely to be predicated from the family. It has been found that the family has a higher frequency and is more susceptible to detecting susceptibility genes for bipolar disorder. Therefore, the family research design combined with WGS, GWAS and other advanced genetic research methods can reduce the unnecessary sample size, eliminate the confounding factors of the population, and more easily capture the potential genes of bipolar disorder.
However, at present, there are few reports of foreign bipolar disorder family and the results are not consistent. There is no research report on the large sample family of Chinese Han population in China. Therefore, it is necessary to expand the family sample size and combine with new genetic research methods in the Han population. explore. Therefore, this study intends to find out the pathogenic genes of bipolar disorder by collecting the two-phase family of Chinese Han population with the large sample using a family cohort study design, combined with the new generation of high-throughput sequencing technology and GWAS, Proteomics, bioinformatics analysis, etc., which is expected to be clarified at the genetic level. The pathogenesis of bipolar disorder. At the same time, the investigators will conduct a five-year follow-up of cognitive function, brain function imaging and other major clinical symptoms in patients with bipolar disorder in the core family, and to explore familial bipolar disorder and sporadic biphasic. Differences in the clinical features of the disorder, in order to explore sensitive and specific biomarkers from a multidimensional perspective (cognitive function, brain imaging, genetic features, clinical features, etc.), which may contribute to bipolar disorder in the future. Accurate diagnosis and early identification and prevention have important scientific significance and clinical diagnosis and treatment significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bipolar disorder family | – | –Screening priori BD-I/BD-II patients， their relatives with mental illness (including but not limited to BD) and their healthy families. |
| health control | – | –Group-matched non-psychiatric family history health subjects were enrolled, DSM-IV-TR is used for demographic assessment. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We intend to expand the sample size of the family, and collect 50 core families and 200 healthy controls at this stage. Similarly, during the validation phase, it is proposed to include 30 core families for verification. To verify the results of the first part of the study in sporadic BD patients and healthy controls, 783 patients with sporadic BD and 692 healthy controls were calculated by sample size estimation formula. With drop-off rate of 20%, 939 cases and 830 cases are needed respectively. In order to avoid other factors falling off, it is proposed to include 1000 cases of sporadic BD patients and healthy controls respectively.
Key inclusion criteria (18 listed)
- BD patients from BD family:
- Healthy menbers from BD family:
- Healthy control enrollment criteria without family history:
Key exclusion criteria (7 listed)
- BD patients from BD family:
- Healthy menbers from BD family and healthy control enrollment criteria without family history::
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
Potential risk genes
Time frame: at december 2022
The investigators will collect peripheral blood samples of patients and healthy controls during the baseline period, and blood samples from family members during follow-up period. The blood will be used for WGS, GWAS, WES to get candidate genes. Reported high risk genes such as CACNA1C、DTNA、FOXP1 and so on are the focus.
9 secondary outcomes
HAMD-17 scores of patients and high-risk subjects
Time frame: by december 2022
Onset age of BD subjects
Time frame: by december 2022
Wisconsin Card Sorting Test results
Time frame: by december 2022
Characteristic changes of electroencephalogram
Time frame: by december 2022
YMRS scores of patients and high-risk subjects
Time frame: by december 2022
Course of disease of BD subjects
Time frame: by december 2022
Treatment plan of BD subjects
Time frame: by december 2022
STROOP test results
Time frame: by december 2022
Repetitive Neuropsychological Status test (RBANS) results
Time frame: by december 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
Yiru Fang principal investigator
Shanghai Mentao Health Center
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, run by Shanghai Mental Health Center 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 18 inclusion and 7 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 18 Jul 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential risk genes (time frame: at december 2022). 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 18 Jul 2019.