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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021800
Receipt No. R000025140
Scientific Title Comparison of atypical antipsychotics for recovery in schizophrenia
Date of disclosure of the study information 2016/05/05
Last modified on 2017/12/05

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Basic information
Public title Comparison of atypical antipsychotics for recovery in schizophrenia
Acronym CARS study
Scientific Title Comparison of atypical antipsychotics for recovery in schizophrenia
Scientific Title:Acronym 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
1st name
Middle name
Last name Kiyokazu Atake
Organization University of Occupational and Environmental Health
Division name department of psyciatry, school of medecine
Zip code
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
1st name
Middle name
Last name Hiroki Beppu
Organization University of Occupational and Environmental Health
Division name department of psyciatry, school of medecine
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 05 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
2016 Year 04 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025140

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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