Unique ID issued by UMIN | UMIN000043575 |
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Receipt number | R000043019 |
Scientific Title | Efficacy, safety, and tolerability of brexpiprazole augmentation for aripiprazole one-monthly in Japanese schizophrenia: A Randomized Controlled Clinical Trial |
Date of disclosure of the study information | 2021/04/01 |
Last modified on | 2021/03/10 13:28:45 |
Efficacy, safety, and tolerability of brexpiprazole augmentation for aripiprazole one-monthly in Japanese schizophrenia: A Randomized Controlled Clinical Trial
BREATH-JS
Efficacy, safety, and tolerability of brexpiprazole augmentation for aripiprazole one-monthly in Japanese schizophrenia: A Randomized Controlled Clinical Trial
BREATH-JS
Japan |
schizophrenia
Psychiatry |
Others
NO
To investigate the effects of brexpiprazole augmentation on efficacy and tolerability in Japanese patients with schizophrenia receiving aripiprazole once-monthly
Safety,Efficacy
Positive and Negative Syndrome Scale (PANSS) from week 0 to week 12
Remission rate, Clinical Global Impression-Severity scale (CGI-S), Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS), UKU Side Effect Scale(UKU), Barnes Akathisia Rating Scale (BARS), Epworth Sleepness Scale(ESS), body weight, Body Mass Index, blood biochemistry, Japanese Adult Reading Test (JART), electroencephalography
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Aripiprazole once-monthly will be maintained at the same dose as baseline for 12 weeks.
Brexpiprazole will be augmented with aripiprazole once-monthly for 12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
Outpatients having a diagnose of schizophrenia or schizoaffective disorder according to ICD-10
Patients who have not been hospitalized in a psychiatric unit in the past 6 months
Baseline total score 120 or less on the PANSS total score
Having regularly and consecutively received aripiprazole once-monthly for at least 2 months
Having provided written informed consent
Serious complication
Active suicidal ideations or past suicide attempts
Drug or alcohol abuse
Pregnant or breast-feeding females
mental retardation
Using of oral aripiprazole or asenapine, blonanserin
Having been judged as unsuitable for the study forin other reasons by an principal investigator
60
1st name | Yoshiteru |
Middle name | |
Last name | Takekita |
Kansai Medical University
Department of Neuropsychiatry
570-8506
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
0669921001
takekity@takii.kmu.ac.jp
1st name | Yoshiteru |
Middle name | |
Last name | Takekita |
Kansai Medical University
Department of Neuropsychiatry
570-8506
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
0669921001
takekity@takii.kmu.ac.jp
Department of Neuropsychiatry, Kansai Medical University
Department of Neuropsychiatry, Kansai Medical University
Other
Institutional Review Board in Kansai Medical University
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
0669921001
rinriirb@hirakata.kmu.ac.jp
NO
関西医科大学総合医療センター(大阪府)、セフィロト病院(滋賀県)、神戸白鷺病院(兵庫県)
2021 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2020 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 02 | Day |
2021 | Year | 04 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 10 | Day |
2021 | Year | 03 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043019
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