UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043575
Receipt number R000043019
Scientific Title Efficacy, safety, and tolerability of brexpiprazole augmentation for aripiprazole one-monthly in Japanese schizophrenia: A Randomized Controlled Clinical Trial
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/10 13:28:45

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Basic information

Public title

Efficacy, safety, and tolerability of brexpiprazole augmentation for aripiprazole one-monthly in Japanese schizophrenia: A Randomized Controlled Clinical Trial

Acronym

BREATH-JS

Scientific Title

Efficacy, safety, and tolerability of brexpiprazole augmentation for aripiprazole one-monthly in Japanese schizophrenia: A Randomized Controlled Clinical Trial

Scientific Title:Acronym

BREATH-JS

Region

Japan


Condition

Condition

schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of brexpiprazole augmentation on efficacy and tolerability in Japanese patients with schizophrenia receiving aripiprazole once-monthly

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive and Negative Syndrome Scale (PANSS) from week 0 to week 12

Key secondary outcomes

Remission rate, Clinical Global Impression-Severity scale (CGI-S), Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS), UKU Side Effect Scale(UKU), Barnes Akathisia Rating Scale (BARS), Epworth Sleepness Scale(ESS), body weight, Body Mass Index, blood biochemistry, Japanese Adult Reading Test (JART), electroencephalography


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aripiprazole once-monthly will be maintained at the same dose as baseline for 12 weeks.

Interventions/Control_2

Brexpiprazole will be augmented with aripiprazole once-monthly for 12 weeks

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients having a diagnose of schizophrenia or schizoaffective disorder according to ICD-10
Patients who have not been hospitalized in a psychiatric unit in the past 6 months
Baseline total score 120 or less on the PANSS total score
Having regularly and consecutively received aripiprazole once-monthly for at least 2 months
Having provided written informed consent

Key exclusion criteria

Serious complication
Active suicidal ideations or past suicide attempts
Drug or alcohol abuse
Pregnant or breast-feeding females
mental retardation
Using of oral aripiprazole or asenapine, blonanserin
Having been judged as unsuitable for the study forin other reasons by an principal investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yoshiteru
Middle name
Last name Takekita

Organization

Kansai Medical University

Division name

Department of Neuropsychiatry

Zip code

570-8506

Address

10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan

TEL

0669921001

Email

takekity@takii.kmu.ac.jp


Public contact

Name of contact person

1st name Yoshiteru
Middle name
Last name Takekita

Organization

Kansai Medical University

Division name

Department of Neuropsychiatry

Zip code

570-8506

Address

10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan

TEL

0669921001

Homepage URL


Email

takekity@takii.kmu.ac.jp


Sponsor or person

Institute

Department of Neuropsychiatry, Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Neuropsychiatry, Kansai Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board in Kansai Medical University

Address

10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan

Tel

0669921001

Email

rinriirb@hirakata.kmu.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

関西医科大学総合医療センター(大阪府)、セフィロト病院(滋賀県)、神戸白鷺病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 01 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


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

Preinitiation

Date of protocol fixation

2020 Year 09 Month 01 Day

Date of IRB

2020 Year 09 Month 02 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 10 Day

Last modified on

2021 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name