Unique ID issued by UMIN | UMIN000033616 |
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Receipt number | R000038088 |
Scientific Title | Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study |
Date of disclosure of the study information | 2018/08/06 |
Last modified on | 2019/02/02 10:50:38 |
Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study
Subjective assessment of brexpiprazole with acute schizophrenia
Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study
Subjective assessment of brexpiprazole with acute schizophrenia
Japan |
Schizophrenia
Psychiatry |
Others
NO
Brexpiprazole has equivalent effectiveness of other antipsychotic agents in Phase I and II clinical trials and their meta-analysis, and is showen to have few side effect such as extrapiramidal symptom, oversedation and weight gain. however, subjective assessment like a well-being not just these objective assessments is important to maintain medication adherence of schizophrenia patients. We examine the subjective assessment of brexpiprazole in 24 weeks open-label study.
Others
We examine SWNS-J, DAI-10 and subjective questionnaire.
Exploratory
Not applicable
SWNS-J (baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
DAI-10 (baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
subjective questionaire
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
brexpiprazole 2mg 24weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1 patients who obtained informed consent
2 20 age or over and under 65 age
3 inpatients and outpatients
4 male and female
5 PANSS-EC >= 4 (one or more items) and CGI-S >= 4
6 patients who had not taken antipsychotic agents for more than two days, or who had taken antipsychotic agents less than 200mg (chlorpromazine equivalence) over three days
1 coma
2 strongly effected of central nervous depressant (e.g. barbiturate)
3 during use epinephrine
4 effected of nervous stimulating (e.g. alcohol)
5 hypersensitivity of brexpiprazole
6 diabetes
7 pregnant women
8 lactating woman
9 history of clozapine
10 treatment-Resistant Schizophrenia
11 inappropriate by physian
12 Mental Retardation
13 dementia
14 Personality disorder
15 brain disorder and severe physical disorder
16 combined paroxetine
17 combined carbamazepine
18 treated electro-convulsive therapy within six month
19 treated long-acting injection within six month
100
1st name | |
Middle name | |
Last name | Masakazu Hatano |
Fujita health university hospital
Pharmacy
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
0562932157
hatanomasakazu@yahoo.co.jp
1st name | |
Middle name | |
Last name | Masakazu Hatano |
Fujita health university hospital
Pharmacy
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
0562932157
hatanomasakazu@yahoo.co.jp
Fujita health university
Fujita health university
Other
NO
藤田保健衛生大学病院(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)
2018 | Year | 08 | Month | 06 | Day |
Unpublished
Case registration was difficult.
Terminated
2018 | Year | 06 | Month | 15 | Day |
2018 | Year | 06 | Month | 15 | Day |
2018 | Year | 08 | Month | 03 | Day |
2019 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038088
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