UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014852 |
|---|---|
| Receipt number | R000017265 |
| Scientific Title | Predictiors of recovery in patients with schizophrenia study |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2016/08/31 23:40:10 |
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Basic information
Public title
Predictiors of recovery in patients with schizophrenia study
Acronym
PREPS study
Scientific Title
Predictiors of recovery in patients with schizophrenia study
Scientific Title:Acronym
PREPS study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Discovery of predictor(s) of recovery in patients with schizophrenia
Basic objectives2
Others
Basic objectives -Others
Discovery of marker for prognosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Discovery of developmental, psychological, and social factors as predictors for recovery and remission in patients with schizophrenia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Questionnaire
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
Key exclusion criteria
- patient(s) who can not understand informed consent document
- comorbidity of substance related disorders
- severe physical disease
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisatsugu Miyata |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL
+81-3-3433-1111
miyata@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumitoshi Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL
+81-3-3433-1111
Homepage URL
kodaka@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
東京慈恵会医科大学精神神経科、公益財団法人復光会総武病院、医療法人社団光生会平川病院、医療法人白百合会大多喜病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | 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
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | 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
| 2014 | Year | 08 | Month | 13 | Day |
Last modified on
| 2016 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017265
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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