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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030871
Receipt No. R000035231
Scientific Title An intervention study for neuronal mechanism of memory and sleep in psychiatric disorders and diagnostic technique development
Date of disclosure of the study information 2018/03/01
Last modified on 2019/07/21

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Basic information
Public title An intervention study for neuronal mechanism of memory and sleep in psychiatric disorders and diagnostic technique development
Acronym An intervention study for neuronal mechanism of memory and sleep in psychiatric disorders
Scientific Title An intervention study for neuronal mechanism of memory and sleep in psychiatric disorders and diagnostic technique development
Scientific Title:Acronym An intervention study for neuronal mechanism of memory and sleep in psychiatric disorders
Region
Japan

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

Objectives
Narrative objectives1 Many psychiatric disorders exhibit memory impairment, and it is now clear that the brain activity during sleep plays an important role in memory formation due to the result of basic neuroscience research in recent years. In fact, it is known that many patients with psychiatric disorders complicate sleep disorders in addition to memory disorders. Therefore, in this research, from the viewpoint of sleep and memory formation, the purpose is to clarify the brain function specificity of patients with mental disorders for memory consolidation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes magnetoencephalography
electroencephalography
MRI
Structured Clinical Interview For DSM-4
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 Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 Participants are required to conduct music memory task. These task-related brain activities are simultaneously recorded with MEG and EEG. Also, we record brain activities during sleep with simultaneous recording with EEG and MEG.
Interventions/Control_2 Participants are required to conduct music memory task. These task-related brain activities are simultaneously recorded with MEG and EEG. Also, we record brain activities during sleep with simultaneous recording with EEG and MEG.
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
14 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 among patients visiting or hospitalized at Gunma University Medical School affiliated hospital.
(b) A person who is identified as a healthy person by SCID-I NP without mental disease / neurological disorder in the present and past.

2. The lower age limit for any of the above (a) and (b) is 15 years, the upper age limits is not concerned.

3. In any of the above (a) and (b), those who are over 20 years old who explained in the consent explanation document and who gained 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 restraints established 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(*): 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. Patients equipped with equipment that MRI contraindicated such as pacemaker, claustrophobia. Subjects during pregnancy are allowed to measure after birth.

2. Persons who are merging serious physical disorders

3. Patients with involuntary admission to a hospital

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 Masato
Middle name
Last name Fukuda
Organization Gunma University
Division name Department of Psychiatry and Neuroscience
Zip code 371-8511
Address 3-39-22 Showa-machi Maebashi City Gunma
TEL 027-220-8187
Email fukuda-psy@gunma-u.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Takei
Organization Gunma University
Division name Department of Psychiatry and Neuroscience
Zip code 371-8511
Address 3-39-22 Showa-machi Maebashi City Gunma
TEL 027-220-8187
Homepage URL
Email tyuichi@gunma-u.ac.jp

Sponsor
Institute Gunma University
Department of Psychiatry and Neuroscience
Institute
Department

Funding Source
Organization Gunma University
Department of Psychiatry and Neuroscience
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Gunma University Hospital
Address 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
Tel 027-220-8740
Email tyuichi@gunma-u.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 群馬大学医学部付属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2018 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2021 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
2018 Year 01 Month 18 Day
Last modified on
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035231

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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