UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictiors of recovery in patients with schizophrenia study
Title of the study (Brief title)	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	Hisatsugu Miyata
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Address	3 Chome-25-8 Nishishinbashi, Minato, Tokyo
TEL	+81-3-3433-1111
Email	miyata@jikei.ac.jp

Public contact
Name of contact person	Fumitoshi Kodaka
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017265