UMIN-CTR Clinical Trial

Basic information
Public title	Development of biomarker in neurodegenerative disease and psychiatric disorders
Acronym	Development of biomarker in neuropsychiatric disorders
Scientific Title	Development of biomarker in neurodegenerative disease and psychiatric disorders
Scientific Title:Acronym	Development of biomarker in neuropsychiatric disorders
Region	Japan

Condition
Condition	Neurodegenerative disease Psychiatric disorder
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	CRMP family protein molecule in the blood, to consider whether early can be a biomarker of neuropsychiatric disorders.
Basic objectives2	Others
Basic objectives -Others	To consider the relationship with neuropsychiatric disorders and CRMP family protein molecule.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity,Specificity,positive and negative likelihood ratios of CRMP family protein molecule in the blood for identifying neuropsychiatric disorders.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
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	Other
Interventions/Control_1	blood test
Interventions/Control_2	cognitive test
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	neurodegenerative disease patients psychiatric disorder patients
Key exclusion criteria	Body complications in critically ill patients Patients who do not have a person that you can substitute the decision of the principal consent capacity, nor the person
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Goshima
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Molecular Pharmacology & Neurobiology
Zip code	2360004
Address	fukuura kanazawa ward yokohama city
TEL	045-783-2594
Email	goshima@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Munetaka Middle name Last name Nomoto
Organization	Yokohama City University Medical Center
Division name	Department of Psychiatry
Zip code	2400026
Address	4-57 Urafunecho minami ward yokohama city kanagawa prefecture
TEL	045-261-5656
Homepage URL
Email	munetaka@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of education,culture,sports,science and technology,JAPAN
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	Yokohama City University Medical Center
Address	4-57 Urafunecho Minami ward Yokohama city Kanagawa prefecture
Tel	045-261-5656
Email	munetaka@yokohama-cu.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	横浜市立大学医学部附属病院 横浜市立大学医学部附属　市民総合医療センター 横浜舞岡病院

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.pnas.org/doi/10.1073/pnas.2100032118
Number of participants that the trial has enrolled	58
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	Completed
Date of protocol fixation	2012 Year 07 Month 06 Day
Date of IRB	2012 Year 07 Month 06 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2022 Year 06 Month 13 Day
Date of closure to data entry	2022 Year 06 Month 13 Day
Date trial data considered complete	2022 Year 06 Month 13 Day
Date analysis concluded	2022 Year 06 Month 13 Day

Other
Other related information

Management information
Registered date	2013 Year 06 Month 05 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012636