UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025245 |
|---|---|
| Receipt number | R000029036 |
| Scientific Title | Intergenerational neuroimaging study of the human brain circuitry in major psychiatric disorders |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2020/12/23 17:27:20 |
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Basic information
Public title
Intergenerational neuroimaging study of the human brain circuitry in major psychiatric disorders
Acronym
Intergenerational study in major psychiatric disorders
Scientific Title
Intergenerational neuroimaging study of the human brain circuitry in major psychiatric disorders
Scientific Title:Acronym
Intergenerational study in major psychiatric disorders
Region
| Japan |
Condition
Condition
Major psychiatric disorder (Schizophrenia, Bipolar disorder, and Depression)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of the current study is to investigate sex-specific intergenerational transmission patterns on the human brain in major psychiatric disorders including depression, bipolar disorder, and schizophrenia. The intergenerational transmission refers to the transfer of traits and behaviors from parents to offspring. Specifically, depression has been shown to exhibit strong matrilineal transmission patterns. A large body of studies has also implicated the corticolimbic circuitry as the biological substrates of emotion. However, to date, there have been no neuroimaging studies that examined the neurobiological evidence of female-specific intergenerational transmission patterns of human brain in depression. We will employ an unique approach of recruiting and assessing combinations of depressed parents and their high-risk offspring using neuroimaging techniques. We hypothesize that depressed mother and high-risk daughter dyads reveal significantly greater association compared to other parent-offspring pairings in the corticolimbic regions.
Other major psychiatric conditions are also considered strongly gender biased. In schizophrenia, diagnosis is much more common in boys and young men than in girls, whereas diagnosis in middle age or older is substantially more frequent in women. Rates of bipolar disorder do not vary between men and women, yet a genetic polymorphism strongly associated with the disorder is relevant to risk in women but not men. Autism spectrum disorder is considered four or five times as prevalent in boys compared in girls. The neurobiological substrates for these sex biases in disease prevalence are still unknown. We therefore believe that understanding the intergenerational transmission of behavioral and neurobiological phenotypes is critical in elucidating the etiology of such sex-biased psychiatric diseases.
Basic objectives2
Others
Basic objectives -Others
Exploring the neurobiological evidence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The brain regions where specific parent-offspring pairs (e,g, depressed mother and high-risk daughter dyads) consistently show greater associations compared to other parent and offspring dyads (e.g, depressed father and high-risk son dyads).
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
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Brain MRI/Parent diagnosed with major psychiatric disorder and healthy offspring pair
Interventions/Control_2
Brain MRI/Healthy parent-offspring pair
Interventions/Control_3
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Schizophrenia, bipolar disorder, and depression diagnosed based on DSM-5 and their healthy biological offsprings
･Healthy parent and their biological offspring pairs
･Healthy controls scored more than 24 points in MMSE or 70 in JART
･Reliable informed consent could be obtained from the patient and or his her relatives
Key exclusion criteria
･Participants were required to have had no lifetime history of any psychiatric disorders, or drug or alcohol misuse, as well as no neurological disorder
･None of the participants reported unstable medical condition and history of significant head trauma.
Target sample size
640
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
Homepage URL
yamagata@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2016 | Year | 12 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029036
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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