UMIN-CTR Clinical Trial

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
Email	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
Email	sharada@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053367