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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000014852
Receipt No. 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

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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
Email 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
Email kodaka@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017265

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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