UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Functional brain imaging study for functional and/or organic psychiatric disorders
Title of the study (Brief title)	Functional brain imaging study for functional and/or organic psychiatric disorders
Region	Japan

Condition
Condition	Schizophrenia, other functional psychiatric disorders and/or organic psychiatric disorders
Classification by specialty	Psychiatry Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of abnormal brain function regions in functional psychiatric disorders and/or organic psychiatric disorders
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain imaging studies (MRI, SPECT, PET), scales for the objective assessment
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	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Antipsychotic drug, PET, CT or MRI, neuropsychological test
Interventions/Control_2	Antipsychotic drug, PET, CT or MRI, neuropsychological test
Interventions/Control_3	PET, CT or MRI, neuropsychological test
Interventions/Control_4	drug trials of < 1000 mg per day chlorpromazine equivalents, in or outpatient status of at least 1 year
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	1) Inpatients or outpatients of Kagoshima University Hospital or Fujimoto Hospital those who are diagnosed by DSM-4, and ICD-10 2) Subjects with schizophrenia, other functional psychiatric disorders or organic psychiatric disorders
Key exclusion criteria	Subjects with head trauma, alcohol or drug abuse in past times
Target sample size	150

Research contact person
Name of lead principal investigator	Akira Sano
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychiatry
Address	8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL	099-275-5346
Email	sano@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Masayuki Nakamura
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychiatry
Address	8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL	099-275-5346
Homepage URL
Email	nakamu36@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Department of Psychiatry, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Department of Psychiatry, Kagoshima University Graduate School of Medical and Dental Sciences Fujimoto Hospital, Fujimoto Medical System
Organization
Division
Category of Funding Organization	Other
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	2015 Year 03 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2005 Year 03 Month 01 Day
Anticipated trial start date	2005 Year 05 Month 09 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 09 Day
Last modified on	2017 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019383