UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044682
Receipt No. R000051007
Scientific Title Treatment persistence and medication adherence in patients with schizophrenia treated with brexpiprazole versus other oral atypical antipsychotic therapy -Cohort study using claim database-
Date of disclosure of the study information 2021/06/30
Last modified on 2021/06/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Treatment persistence and medication adherence in patients with schizophrenia treated with brexpiprazole versus other oral atypical antipsychotic therapy -Cohort study using claim database-
Acronym Treatment persistence and medication adherence in patients with schizophrenia treated with brexpiprazole versus other oral atypical antipsychotic therapy -Cohort study using claim database-
Scientific Title Treatment persistence and medication adherence in patients with schizophrenia treated with brexpiprazole versus other oral atypical antipsychotic therapy -Cohort study using claim database-
Scientific Title:Acronym Treatment persistence and medication adherence in patients with schizophrenia treated with brexpiprazole versus other oral atypical antipsychotic therapy -Cohort study using claim database-
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To exploratory compare the duration of treatment persistence between brexpiprazole (BRX) and oral atypical antipsychotics (OAA) groups in patients with schizophrenia who were newly prescribed BRX and OAA in Japan during the enrollment period.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Duration of treatment persistence with the BRX and OAA groups in patients with schizophrenia
Key secondary outcomes Duration of treatment persistence of the BRX and each drug of OAA* in schizophrenia.

Percentage of patients with good adherence to schizophrenia (PDC>=0.8) by BRX, OAA group, and each drug of OAA*.

*Excluding drugs with a small sample size

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. Enrollment period from April 18, 2018 to November 30, 2019
2. Extract patients with schizophrenia who started treatment with BRX during the enrollment period as the BRX group preferentially, then extract patients with schizophrenia who started treatment with atypical antipsychotics other than BRX for schizophrenia during the enrollment period.
*Patients who do not prescribe the index drug for any disease for 60 days prior to index date
3. Patients with a diagnosis record for schizophrenia on admission or at two or more outpatient visits in 365-day pre-index date.
4. Patients aged 18 years or older at index date
Key exclusion criteria 1. Patients diagnosed with the following diseases in the month of index date or during the 12-month pre-index period.
Dementia
Attention-Deficit Hyperactivity Disorder (ADHD)
Intellectual disability
2. Patients receiving concomitant atypical antipsychotics other than the index drug for more than 30 days after index date
3. Patients who have been prescribed long-acting injectable antipsychotics within 60 days prior to index date
4. Patients who prescribed clozapine in 365-day pre-index date
Target sample size 6000

Research contact person
Name of lead principal investigator
1st name Inuyama
Middle name
Last name Lyo
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs Department
Zip code 108-8242
Address Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL 03-6717-1400
Email Inuyama.Lyo@otsuka.jp

Public contact
Name of contact person
1st name Sekine
Middle name
Last name Daisuke
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs Department
Zip code 108-8242
Address Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL 03-6717-1400
Homepage URL
Email sekined@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 06 Month 30 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 5876
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
2020 Year 11 Month 25 Day
Date of IRB
2020 Year 11 Month 25 Day
Anticipated trial start date
2021 Year 01 Month 21 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To exploratory compare the duration of treatment persistence between brexpiprazole (BRX) and oral atypical antipsychotics (OAA) groups in patients with schizophrenia who were newly prescribed BRX and OAA in Japan during the enrollment period.

Management information
Registered date
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.