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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030309
Receipt No. R000034612
Scientific Title A prospective observational study of brain mechanism related to sleep and memory in psychiatric disorder for diagnostics development.
Date of disclosure of the study information 2017/12/08
Last modified on 2017/12/08

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Basic information
Public title A prospective observational study of brain mechanism related to sleep and memory in psychiatric disorder for diagnostics development.
Acronym Investigation of brain mechanism of sleep and memory in psychiatric disorder
Scientific Title A prospective observational study of brain mechanism related to sleep and memory in psychiatric disorder for diagnostics development.
Scientific Title:Acronym Investigation of brain mechanism of sleep and memory in psychiatric disorder
Region
Japan

Condition
Condition psychiatric disorder
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate detailed temporal and spatial brain mechanism of spindle /low beta activity responsible for memory formation and investigate the mechanism of memory deficits formation process of psychiatric disorder.
Basic objectives2 Others
Basic objectives -Others Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in spindle / low beta activity during sleep and awake in psychiatric disorder.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) One who falls under either a. or b.
a. Person who is diagnosed as a corresponding psychiatric disorder in accordance with DSM - 5 and is informed of the disease name or a state image equivalent thereto, among patients visiting or hospitalized at Gunma University Medical School affiliated hospital.
b. Persons who have no mental illness / neurological disorder in the present and past and were identified as healthy subjects by SCID-I NP.
2) The minimum age limit for any of the above a., B. Is 15 years, the maximum age limit is not concerned.
3) In any of the above a., B., Those who are over 20 years old who explained in the consent explanation document and obtained participation consent by self-registered signature in the consent form.
4) Among the group of mental illnesses in a., Those who are hospitalized and who are hospitalized medical inpatients prescribed by the Mental Health and Welfare Law and who are voluntarily hospitalized patients who are in hospitalization and are within discharge limits or are subject to the quarantine / physical restraint determined by the Mental Health and Welfare Law Patients who are under enforcement, patients with age between 15 and under - 20 years old, the principal and the substitute person (family members etc defined by the mental health and welfare law: spouse, custodian, guardian or curator, dependent supporter Those who gained consent from the documents from both [direct family members, brothers and sisters and family courts within three parents, etc, which are appointed by civil law]]).
5) In the healthy group of b., Those who aged 15 to over - 20 years old have obtained written consent from both the principal and the substitute (Note).
Note: Dependent persons to be supported: According to the provisions of the Civil Code, they are regarded as family members of direct lineage, brothers and sisters and families within the third degree appointed to family court.
Key exclusion criteria 1) Pacemaker, claustrophobia etc. MRI equipment contraindicated (see screening sheet * subjects during pregnancy are allowed to measure after birth)
2) Persons who are merging serious physical disorders
3) Measures Inpatients
4) Emergency hospitalized patients
5) Others judged unsuitable as subjects by doctors
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fukuda Masato
Organization Gunma University Graduate School of Medicine
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8180
Email fukuda-psy@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takei Yuichi
Organization Gunma University Graduate School of Medicine
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8190
Homepage URL
Email tyuichi@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
2017 Year 12 Month 08 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2017 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034612

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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