UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective,multicenter, randomized, parallel-group,open-label study of aripiprazole in the management of patients with schizophrenia
Title of the study (Brief title)	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	Masaomi Iyo
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Psychiatry
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2148
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	Tomihisa Niitsu
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2008 Year 12 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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