UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030991 |
|---|---|
| Receipt number | R000035319 |
| Scientific Title | The effect on brain structure and function of psychosocial intervention program to schizophrenia patients:MRI study |
| Date of disclosure of the study information | 2018/01/26 |
| Last modified on | 2024/02/03 23:33:01 |
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Basic information
Public title
The effect on brain structure and function of psychosocial intervention program to schizophrenia patients:MRI study
Acronym
The effect on brain structure and function of psychosocial intervention program to schizophrenia patients:MRI study
Scientific Title
The effect on brain structure and function of psychosocial intervention program to schizophrenia patients:MRI study
Scientific Title:Acronym
The effect on brain structure and function of psychosocial intervention program to schizophrenia patients:MRI study
Region
| Japan |
Condition
Condition
schizophrenia patients
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect on brain structure and function of Illness management and recovery by MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of brain structure and function before and after the implementation of Illness management and recovery
Key secondary outcomes
The relationship between brain change and objective or subjective 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of Illness management and recovery
Interventions/Control_2
treatment as usual
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
#schizophrenia patients diagnosed by DSM-V
#MRI-safe
#outpatients
Key exclusion criteria
the patients who had a lifetime history of substance abuse, seizures, head trauma with loss of consciousness, or diagnosed neurological disorders
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Yoshimi |
Organization
School of Medicine, Yokohama city university
Division name
Department of Psychiatry
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2667
yoshimia@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Yoshimi |
Organization
Department of Medicine, Yokohama city university
Division name
Psychiatry
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2667
Homepage URL
yoshimia@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university, ethics committe
Address
3-9 Fukuura, Kanazawa-ku,Yokohama
Tel
0453707627
ynextedu@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
17K10337
Org. issuing International ID_1
Ministry of Health, Labour and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035319
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/07/29 | 研究計画書第4版 20210724.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
