UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046953 |
|---|---|
| Receipt number | R000053367 |
| Scientific Title | Brain imaging research to elucidate the pathophysiology of bipolar disorder |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/09/01 15:49:18 |
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Basic information
Public title
Brain imaging research to understand mania and depression
Acronym
Brain imaging of mania and depression
Scientific Title
Brain imaging research to elucidate the pathophysiology of bipolar disorder
Scientific Title:Acronym
Brain imaging of bipolar disorder
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify intrafamilial genetic factors in brain mechanism by comparing brain morphology, brain function, mental status assessment, and neuropsychological testing in bipolar disorder probands and their first-degree relatives.
Basic objectives2
Others
Basic objectives -Others
To identify intrafamilial genetic factors in brain pathology by comparing brain morphology, brain function, mental status assessment, and neuropsychological testing in bipolar disorder probands and their first-degree relatives.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine functional and structural dissimilarities in patients with bipolar disorder and their first-degree relatives, as well as in healthy subjects, by analyzing MRI and NIRS data.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Bipolar disorder patients: To examine NIRS, MRI and clinical assesments
Interventions/Control_2
First degree relatives: To examine NIRS, MRI and clinical assesments
Interventions/Control_3
Healthy subjects: To examine NIRS, MRI and clinical assesments
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Bipolar disorder patients
Patients who met the diagnostic criteria for bipolar disorder based on the "Diagnostic and Statistical Manual of Mental Disorder" prepared by the American Psychiatric Association.
The proband and two first-degree relatives of the proband, for a total of three people who can participate.
Inpatient or outpatient is not required.
The diagnosis will be made by clinical diagnostic interview and MINI.
It does not matter if they are taking medication or not.
First-degree relatives of bipolar disorder patients
The proband is participating in this study.
They are not schizophrenia or bipolar disorder.
They will be screened by clinical interview and structural interview MINI.
Healthy subjects
Applicants who have not been found to have neurological or psychiatric disorders by clinical interview and MINI.
Key exclusion criteria
All subjects
Subjects with an intelligence quotient (IQ) of less than 70 or a similar educational background (e.g., graduation from a support school).
History of head trauma with loss of consciousness.
Serious medical illness (e.g., acute leukemia or recurrent severe asthma attacks) or unstable medical illness (e.g., severe liver damage (AST or ALT of 100 IU or more), renal failure, or abnormal thyroid function) that is currently being treated with different medications or is judged by a physician to require hospitalization.
First-degree relatives with neuromuscular diseases (Parkinson's disease, epilepsy, multiple sclerosis, etc.).
Those who are judged by the researcher to be unsuitable as subjects (e.g., repeated suicide attempts).
Healthy subjects
Those who have been diagnosed as having a mental illness by the structured interview (MINI).
Those who have a first-degree blood relative with a mental illness.
Patients with a history of continuous use of antipsychotic or antidepressant medication.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Saitama Medical University Hospital
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama
TEL
0492761214
kmatsuo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Harada |
Organization
Saitama Medical University Hospital
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama
TEL
0492761214
Homepage URL
sharada@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital
Address
38 Morohongo, Moroyama, Iruma, Saitama
Tel
0492761354
hirb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053367
