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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025245
Receipt No. 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 2017/08/13

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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
Middle name
Last name Masaru Mimura
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
TEL 03-3353-1211
Email mimura@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Bun Yamagata
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email yamagata@a6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Address
Tel
Email

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
2017 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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