UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051998 |
|---|---|
| Receipt number | R000059350 |
| Scientific Title | Persistence in patients with acute schizophrenia treated with brexpiprazole in the Japanese clinical practice: a retrospective 6-month follow-up study |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2023/08/24 20:38:02 |
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Basic information
Public title
Persistence in patients with acute schizophrenia treated with brexpiprazole in the Japanese clinical practice: a retrospective 6-month follow-up study
Acronym
Persistence in patients with acute schizophrenia treated with brexpiprazole in the Japanese clinical practice
Scientific Title
Persistence in patients with acute schizophrenia treated with brexpiprazole in the Japanese clinical practice: a retrospective 6-month follow-up study
Scientific Title:Acronym
Persistence in patients with acute schizophrenia treated with brexpiprazole in the Japanese clinical practice
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the treatment continuation rates and incidence of adverse effects in the patients of schizophrenia administering brexpiprazole .
Basic objectives2
Others
Basic objectives -Others
To calculated total dose of antipsychotics and benzodiazepine by converting the dose to chlorpromazine and diazepam equivalents, respectively .
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
continuation rates and incidence of adverse effects
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients at Karasuyama Hospital of Showa University. Patients who were diagnosed with schizophrenia according to the definitions outlined in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, and who were prescribed brexpiprazole at acute ward between August 2018 and August 2023.
Key exclusion criteria
Nothing
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Shinmura |
Organization
Showa University School of Medicine
Division name
Department of Psychiatry
Zip code
157-8577
Address
6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo,Japan
TEL
0333005231
samurai.golf@med.showa-u.co.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Shinmura |
Organization
Showa University School of Medicine
Division name
Department of Psychiatry
Zip code
157-8577
Address
6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo,Japan
TEL
0333005231
Homepage URL
samurai.golf@med.showa-u.co.jp
Sponsor or person
Institute
Showa University School of Medicine
Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8,hatanodai,sinagawa-ku,Tokyo,Japan
Tel
0337848129
m-rinri@ofc.showa-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 31 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To research Persistence in patients with acute schizophrenia treated with brexpiprazole in the Japanese clinical practice.
We extracted data on patient characteristics (age, sex, and treatment history) and clinical course(treatment continuation rates , incidence of adverse effects, and dose of benzodiazepine). The total dose of antipsychotics and benzodiazepine was calculated by converting the dose to chlorpromazine and diazepam equivalents, respectively.
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059350
