UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of medication adherence of blonanserin and aripiprazole in schizophrenic patients: a multicenter, randomized, open-label study
Title of the study (Brief title)	A-BLAS
Region	Japan

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

Objectives
Narrative objectives1	A comparison of medication adherence of blonanserin and aripiprazole in schizophrenic patients: a multicenter, randomized, open-label study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PANSS,DAI-10,CGI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are 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	Blonanserin
Interventions/Control_2	Aripiprazole
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Schizophrenia
Key exclusion criteria	nothing particulary
Target sample size	200

Research contact person
Name of lead principal investigator	Jun Nakamura
Organization	University of Occupational and Environmental Health
Division name	Department of Psychiatry
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	093-691-7253
Email	jun@med.uoeh-u.ac.jp

Public contact
Name of contact person	Hikaru Hori
Organization	University of Occupational and Environmental Health
Division name	Department of Psychiatry
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	093-691-7253
Homepage URL
Email	hori-h@med.uoeh-u.ac.jp

Sponsor
Institute	UOEH
Institute
Department

Funding Source
Organization	UOEH
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	2013 Year 12 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 01 Month 01 Day
Anticipated trial start date	2012 Year 02 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 30 Day
Last modified on	2019 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014870