UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032339 |
|---|---|
| Receipt number | 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 10:01:40 |
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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
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
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036874
