UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A high-resolution MRI analysis in psychiatric disorders
Title of the study (Brief title)	A high-resolution MRI analysis in psychiatric disorders
Region	Japan

Condition
Condition	Healthy control Schizophrenia Mood disorder Epilepsy
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the neural basis of psychiatric disorders and establish an objective indicator that is useful for early diagnosis and screening by detailed structural analysis of the brain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	volumes of region of interest
Key secondary outcomes	FA(fractional anisotropy) PANSS SAPS SANS SES(socioeconomic status)

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	5
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	MRI,neuropsychological test
Interventions/Control_2	MRI,neuropsychological test
Interventions/Control_3	MRI,neuropsychological test
Interventions/Control_4	MRI,neuropsychological test
Interventions/Control_5	MRI,neuropsychological test
Interventions/Control_6
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	1) Right-handed 2) Inpatients or outpatients of Kyushu-university hospital those who are diagnosed by DSM-4, and ICD-10
Key exclusion criteria	1) Subjects with neurological illness or major head trauma 2) Subjects with alcohol or drug abuse within the past five years 3) Subjects with a verbal intelligence quotient below 75 4) Healthy controls with Axis 1 disorder in themselves or a first-degree relative, which were screened using the Structured Clinical Interview (SCID), non-patient edition. 5) Subjects who have contraindication to MRI
Target sample size	200

Research contact person
Name of lead principal investigator	Shigenobu Kanba
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Neuropsychiatry
Address	Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL	092-641-1151
Email	skanba@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person	Toshiaki Onitsuka
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Neuropsychiatry
Address	Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL	092-641-1151
Homepage URL
Email	toshiaki@npsych.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 28 Day
Anticipated trial start date	2014 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 08 Month 04 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017099