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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034583
Receipt No. R000038826
Scientific Title Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Date of disclosure of the study information 2018/10/31
Last modified on 2018/10/20

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Basic information
Public title Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Acronym Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Scientific Title Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Scientific Title:Acronym Understanding the neuropathophysiology of psychological distress symptoms associated with life events using functional magnetic resonance imaging
Region
Japan

Condition
Condition Bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarifying pathology
Basic objectives2 Others
Basic objectives -Others Clarifying pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neural functioning
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Bipolar disorder
Key exclusion criteria 1. Subjects with dementia
2. Subjects with organic mental disorder
3. Subjects with schizophrenia
4. Subjects with post traumatic stress disorder
5. Subjects with intellectual disability
6. Subjects with impending suicide attempt
7. Subjects who have contraindication to MRI
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Graduate school of medicine and school of medicine, Chiba university
Division name Department of psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-222-7171
Email ahda4468@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Seki
Organization Graduate school of medicine and school of medicine, Chiba university
Division name Department of psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-222-7171
Homepage URL
Email ahda4468@chiba-u.jp

Sponsor
Institute Chiba university hospital
Institute
Department

Funding Source
Organization Department of psychiatry, graduate school of medicine and school of medicine, Chiba university
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 10 Month 31 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
2018 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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 Not applicable

Management information
Registered date
2018 Year 10 Month 20 Day
Last modified on
2018 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038826

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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