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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001650
Receipt No. R000001988
Scientific Title A prospective,multicenter, randomized, parallel-group,open-label study of aripiprazole in the management of patients with schizophrenia
Date of disclosure of the study information 2009/01/22
Last modified on 2019/02/28

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Basic information
Public title A prospective,multicenter,
randomized,
parallel-group,open-label study of
aripiprazole in the management of
patients with schizophrenia
Acronym Chiba Broad Effectiveness Trial With
Aripiprazole (Chiba-BETA)
Scientific Title A prospective,multicenter,
randomized,
parallel-group,open-label study of
aripiprazole in the management of
patients with schizophrenia
Scientific Title:Acronym Chiba Broad Effectiveness Trial With
Aripiprazole (Chiba-BETA)
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was designed to evaluate
The overall effectiveness of
aripiprazole in patients with
schizophrenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Preference of Medicine(POM)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aripiprazole
Interventions/Control_2 Standard control
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria With a diagnosis of schizophrenia and noticed as schizophrenia.
Outpatients.
Taking a certain antipsychotic four weeks long.
A switch from current antipsychotic medicine was judged clinically reasonable.
Key exclusion criteria Pregnant or breastfeeding women.
Not noticed as schizophrenia.
With diabetes.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Graduate School of Medicine, Chiba University
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-226-2148
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomihisa Niitsu
Organization Graduate School of Medicine, Chiba University
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2148
Homepage URL
Email niitsu@chiba-u.jp

Sponsor
Institute Department of Psychiatry, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Graduate School of Medicine, Chiba University
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

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 22 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 Terminated
Date of protocol fixation
2008 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 21 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001988

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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