A Genetic Family Cohort Study of Bipolar Disorder in Chinese Han Population

NCT04024553 | Unknown

• 1 other identifier: CRC2018ZD02
• Study Type: observational
• Target: 2,520
• Locations: 1 country
• Sites: 1

Brief 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), 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

Outcome Measures

Primary Outcomes (1)

• 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.

  at december 2022

Secondary Outcomes (9)

• HAMD-17 scores of patients and high-risk subjects

  by december 2022

• Onset age of BD subjects

  by december 2022

• Wisconsin Card Sorting Test results

  by december 2022

• Characteristic changes of electroencephalogram

  by december 2022

• YMRS scores of patients and high-risk subjects

  by december 2022

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collect 5 ml of venous blood of subjects with empty stomach into the 2% EDTA anticoagulation tube from 7 am to 9 am, for subsequent extraction of whole blood DNA and determination of plasma protein; simultaneously collect 2 ml of venous blood into PAXgene Blood RNA Tube and gently invert 10 times, placed vertically for subsequent extraction of whole blood RNA.

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Yiru Fang

  Shanghai Mentao Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 18, 2019
• Study Start: March 28, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: July 18, 2019

Record last verified: 2019-06

Locations

CN (1)