UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of functional magnetic resonance imaging for the evaluation of the neural basis of the symptoms and state of mental illness.
Title of the study (Brief title)	fMRI study for neural basis of the mental illness.
Region	Japan

Condition
Condition	healthy volunteer schizophrenia mood disorders neurotic disorders disorders of psychological development behavioural and emotional disorders
Classification by specialty	Pediatrics Psychiatry Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the neural basis of the mental illness by multi-modality of magnetic resonance imaging.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of signal of brain morphometry, difussion tensor imagign, neuromelanin imaging, and functional magnetic resonance imaging.
Key secondary outcomes	neuropsychological examination

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	6
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	MRI, neuropsychological batteries
Interventions/Control_2	MRI, neuropsychological batteries
Interventions/Control_3	MRI, neuropsychological batteries
Interventions/Control_4	MRI, neuropsychological batteries
Interventions/Control_5	MRI, neuropsychological batteries
Interventions/Control_6	MRI, neuropsychological batteries
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy volunteers - without past or current history of mental illnesses illnesses groups - who met the diagnostic criteria of F2, F3, F4, F8, F9 code of ICD-10
Key exclusion criteria	Exclusion criteria: - With past or current history of serious medical illness and/or brain organic diseases - Subject who is contraindicated for the use of MRI - With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy - Subjects who are judged as not suitable for participation in this study
Target sample size	180

Research contact person
Name of lead principal investigator	Yoshiro Okubo, MD., Ph.D.
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyom 113-8603, Japan
TEL	03-3822-2131
Email	okubo-y@nms.ac.jp

Public contact
Name of contact person	Amane Tateno, M.D., Ph.D.
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Homepage URL
Email	amtateno@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	日本医科大学付属病院精神神経科、日本医科大学薬理学教室、日本医科大学健診医療センター、玉川大学・脳科学研究所、八重洲クリニック

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 14 Day
Anticipated trial start date	2013 Year 05 Month 16 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 14 Day
Last modified on	2017 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012524