UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045075 |
|---|---|
| Receipt number | R000051494 |
| Scientific Title | A Study on the factors associated with continuing treatment with brexpiprazole in patients with schizophrenia using MENTAT |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2022/05/26 11:42:31 |
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Basic information
Public title
A Study on the factors associated with continuing treatment with brexpiprazole in patients with schizophrenia using MENTAT
Acronym
A Study on the factors associated with continuing treatment with brexpiprazole in patients with schizophrenia using MENTAT
Scientific Title
A Study on the factors associated with continuing treatment with brexpiprazole in patients with schizophrenia using MENTAT
Scientific Title:Acronym
A Study on the factors associated with continuing treatment with brexpiprazole in patients with schizophrenia using MENTAT
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o exploratively study the factors affecting the continuing treatment duration in patients with schizophrenia who started treatment with brexpiprazole.
Basic objectives2
Others
Basic objectives -Others
Treatment continuation rates with brexpiprazole
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To exploratively study the factors affecting the continuing treatment duration in patients with schizophrenia who started treatment with brexpiprazole
Key secondary outcomes
Treatment continuation rates with brexpiprazole
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who started treatment with brexpiprazole for schizophrenia within the enrollment period (April 18, 2018 to March 31, 2020) (Index date is defined as the earliest date of prescription at the time of diagnosis of schizophrenia within the enrollment period)
2)Patients aged 18 years or older on the index date
Key exclusion criteria
1) Patients with mood [affective] disorder, dementia, disorders of psychological development, or hyperactivity disorder at the time of Index date
2) Patients who have been treated with brexpiprazole less than 1 mg / day and more than 2 mg / day even once
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Akiyoshi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
108-8242
Address
2-16-4 konan,Minato-ku,Tokyo
TEL
03-6717-1400
akiyoshih@otsuka.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Akiyoshi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
108-8242
Address
2-16-4 konan,Minato-ku,Tokyo
TEL
03-6717-1400
Homepage URL
akiyoshih@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd.
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Imaizumi.Takashi@otsuka.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
| 2021 | Year | 08 | Month | 20 | 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
37534
Results
Eight factors were extracted from the results of multivariate analysis using the Cox proportional hazards regression model. Of these, "symptoms other than positive symptoms (after 28 days)," "ECT," "time of BRX 2 mg dose increase," "key person (with contact information)," and "reports and crimes" had hazard ratios of 1 or greater, while "physical complications," "maximum pre-start CP-equivalent dose category 1 (200-400 mg)" and "hospital days" had hazard ratios less than 1.
Results date posted
| 2022 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age 48.0 (SD 15.3) year, male 47.8% (246/515), inpatients 64.7% (333/515), outpatients 35.3% (182/515), 4.7% with ECT experience, CP equivalent before start (maximum value during the past year) 724.35 (SD 726.21) mg/day, etc.
Participant flow
There were 37,534 patients enrolled in the database obtained from MENTAT (4/18/2018 to 5/15/2020), 5,551 of whom had schizophrenia (ICD-10, F20). 515 patients met the eligibility criteria for the study.
Adverse events
Not applicable because this study is a factor study that affects treatment continuation.
Outcome measures
Detection of factors affecting duration of treatment with Brexpiprazole
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Study on the factors associated with continuing treatment with brexpiprazole in patients with schizophrenia using a data created by text mining
Management information
Registered date
| 2021 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051494
