UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of atypical antipsychotics for recovery in schizophrenia
Title of the study (Brief title)	CARS study
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	A 52-week randomized open-label study of asenapine, olanzapine and blonanserin in the treatment of Japanese schizophrenia patients: data from neurocognitive function, social function and decision making.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in PANSS scores.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	asenapine
Interventions/Control_2	olanzapine
Interventions/Control_3	blonanserin
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for primary diagnosis of schizophrenia obtein the patient's informed consent using some documents who can be treated following the protocol
Key exclusion criteria	treatment resistant schizophrenia suffering from a potentially deadly disease history of convulsive disorders such as epilepsy, or organic brain syndrome parkinson's disease diabetes history of neuroleptic malignant syndrome history of substance abuse pregnancy or breastfeeding women
Target sample size	300

Research contact person
Name of lead principal investigator	Kiyokazu Atake
Organization	University of Occupational and Environmental Health
Division name	department of psyciatry, school of medecine
Address	1-1, iseigaoka, yahatanishi-ku, kitakyusyu
TEL	093-691-7253
Email	k-atake@med.uoeh-u.ac.jp

Public contact
Name of contact person	Hiroki Beppu
Organization	University of Occupational and Environmental Health
Division name	department of psyciatry, school of medecine
Address	1-1, iseigaoka, yahatanishi-ku, kitakyusyu
TEL	093-691-7253
Homepage URL
Email	hirokibeppu@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, School of medicine, department of psychiatry
Institute
Department

Funding Source
Organization	University of Occupational and Environmental Health, School of medicine, department of psychiatry
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 05 Day
Anticipated trial start date	2016 Year 05 Month 05 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	2016 Year 04 Month 06 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025140