A Genetic Family Cohort Study of Bipolar Disorder in Chinese Han Population
NCT04024553, Unknown, Shanghai Mental Health Center
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Genetic Family Cohort Study of Bipolar Disorder in Chinese Han Population | ClinicalTrials.gov |
| NCT number | NCT04024553 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 2,520 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Mental Health Center | ClinicalTrials.gov |
| Conditions | Bipolar Disorder | ClinicalTrials.gov |
| First posted | 2019-07-18 | ClinicalTrials.gov |
| Last updated | 2019-07-18 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Potential risk genes | 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. | ClinicalTrials.gov |
| Secondary | HAMD-17 scores of patients and high-risk subjects | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | Onset age of BD subjects | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | Wisconsin Card Sorting Test results | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | Characteristic changes of electroencephalogram | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | YMRS scores of patients and high-risk subjects | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | Course of disease of BD subjects | by december 2022 | Disease course will be record since the subjects join this peoject, and until the end of this study. | ClinicalTrials.gov |
| Secondary | Treatment plan of BD subjects | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | STROOP test results | by december 2022 | 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. | ClinicalTrials.gov |
| Secondary | Repetitive Neuropsychological Status test (RBANS) results | by december 2022 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)