UMIN-CTR Clinical Trial

Basic information
Public title	Brexpiprazole for the treatment of acute schizophrenia in the Japanese population
Acronym	Brexpiprazole for acute schizophrenia
Scientific Title	Brexpiprazole for the treatment of acute schizophrenia in the Japanese population
Scientific Title:Acronym	Brexpiprazole for acute schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	Examination whether brexpiprazole has a benefit for the treatment of acute schizophrenia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	All causes discontinuation
Key secondary outcomes	Discontinuation due to adverse events, discontinuation due to inefficacy, the improvement of psychopathology, individual adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Brexpiprazole 2mg/day (6 weeks, open label study)
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. The patient understands and agrees to all the risks and all the benefits of the proposed study 2. inpatient and outpatient 3. male and femele 4. PANSS-EC total score of. >=14 with one or more individual items scoring>=4 and CGI-S>=4 5. not receiving antipsychotic for>=2 days before the study or receiving antipsychotic (Chlorpromazine equivalent doses<=200mg/day) for>=3 days before the study
Key exclusion criteria	1. the patient with coma 2. the patient receiving anesthetic agent or barbiturate 3. the patient receiving epinephrine 4. the patient receiving psychostimulant 5. the patient having allergy brexpiprazole 6, the patient with DM 7. the patient with pregnancy 8. the patient with breast-feeding 9. the patient receiving clozapine 10. the patient suitable for clozapine 11. the patient who the clinician do not suggest to entry the study 12. the patient with mental retardation 13. the patient with dementia 14. the patient with personality disorder 15. the patient with organic brain disease and/or severe physical disease 16. the patient receiving paroxetine 17. the patient receiving carbamazepine 18. the patient receiving electroconvulsive therapy within 6 months before the study 19. the patient receiving long-acting injectable antipsychotics within 6 months before the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nakao Iwata
Organization	Fujita Health University School of Medicine
Division name	Psychiatry
Zip code
Address	1-98 Kusukake-cho Dengakugakubo, Toyoake, Aichi 470-1192
TEL	0562-93-9250
Email	nakao@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Taro Kishi
Organization	Fujita Health University School of Medicine
Division name	Psychiatry
Zip code
Address	1-98 Kusukake-cho Dengakugakubo, Toyoake, Aichi 470-1192
TEL	0562-93-9250
Homepage URL
Email	tarok@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	none
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	藤田保健衛生大学（愛知県） 桶狭間病院　藤田こころケアセンター（愛知県） 藤田メンタルケアサテライト（愛知県） 藤田メンタルケアサテライト徳重北（愛知県） 仁大病院（愛知県） 聖十字病院（岐阜県） 刈谷病院（愛知県） もりやま総合心療病院（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 21 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	2018 Year 04 Month 21 Day
Date of IRB	2018 Year 10 Month 19 Day
Anticipated trial start date	2018 Year 04 Month 21 Day
Last follow-up date	2019 Year 10 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 21 Day
Last modified on	2019 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036874