UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030871 |
|---|---|
| Receipt number | 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 09:37:54 |
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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
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
tyuichi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Department of Psychiatry and Neuroscience
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035231
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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