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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016752
Receipt No. R000019383
Scientific Title Functional brain imaging study for functional and/or organic psychiatric disorders
Date of disclosure of the study information 2015/03/10
Last modified on 2017/10/02

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Basic information
Public title Functional brain imaging study for functional and/or organic psychiatric disorders
Acronym Functional brain imaging study for functional and/or organic psychiatric disorders
Scientific Title Functional brain imaging study for functional and/or organic psychiatric disorders
Scientific Title:Acronym 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
1st name
Middle name
Last name Akira Sano
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Psychiatry
Zip code
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
1st name
Middle name
Last name Masayuki Nakamura
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Psychiatry
Zip code
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)

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
2015 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2005 Year 03 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019383

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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