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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051494


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name