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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032339
Receipt No. R000036874
Scientific Title Brexpiprazole for the treatment of acute schizophrenia in the Japanese population
Date of disclosure of the study information 2018/04/21
Last modified on 2019/10/24

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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/ctr_e/ctr_view.cgi?recptno=R000036874

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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