UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016752 |
|---|---|
| Receipt number | 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 10:37:15 |
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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
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
nakamu36@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019383
