UMIN-CTR Clinical Trial

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
Email	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
Email	akiyoshih@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051494