UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033616
Receipt number R000038088
Scientific Title Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study
Date of disclosure of the study information 2018/08/06
Last modified on 2019/02/02 10:50:38

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Basic information

Public title

Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study

Acronym

Subjective assessment of brexpiprazole with acute schizophrenia

Scientific Title

Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study

Scientific Title:Acronym

Subjective assessment of brexpiprazole with acute schizophrenia

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Brexpiprazole has equivalent effectiveness of other antipsychotic agents in Phase I and II clinical trials and their meta-analysis, and is showen to have few side effect such as extrapiramidal symptom, oversedation and weight gain. however, subjective assessment like a well-being not just these objective assessments is important to maintain medication adherence of schizophrenia patients. We examine the subjective assessment of brexpiprazole in 24 weeks open-label study.

Basic objectives2

Others

Basic objectives -Others

We examine SWNS-J, DAI-10 and subjective questionnaire.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

SWNS-J (baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)

Key secondary outcomes

DAI-10 (baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks)
subjective questionaire


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

brexpiprazole 2mg 24weeks

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1 patients who obtained informed consent
2 20 age or over and under 65 age
3 inpatients and outpatients
4 male and female
5 PANSS-EC >= 4 (one or more items) and CGI-S >= 4
6 patients who had not taken antipsychotic agents for more than two days, or who had taken antipsychotic agents less than 200mg (chlorpromazine equivalence) over three days

Key exclusion criteria

1 coma
2 strongly effected of central nervous depressant (e.g. barbiturate)
3 during use epinephrine
4 effected of nervous stimulating (e.g. alcohol)
5 hypersensitivity of brexpiprazole
6 diabetes
7 pregnant women
8 lactating woman
9 history of clozapine
10 treatment-Resistant Schizophrenia
11 inappropriate by physian
12 Mental Retardation
13 dementia
14 Personality disorder
15 brain disorder and severe physical disorder
16 combined paroxetine
17 combined carbamazepine
18 treated electro-convulsive therapy within six month
19 treated long-acting injection within six month

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Hatano

Organization

Fujita health university hospital

Division name

Pharmacy

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi

TEL

0562932157

Email

hatanomasakazu@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masakazu Hatano

Organization

Fujita health university hospital

Division name

Pharmacy

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi

TEL

0562932157

Homepage URL


Email

hatanomasakazu@yahoo.co.jp


Sponsor or person

Institute

Fujita health university

Institute

Department

Personal name



Funding Source

Organization

Fujita health 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


Address


Tel


Email



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

藤田保健衛生大学病院(愛知県)、桶狭間病院藤田こころケアセンター(愛知県)、藤田メンタルケアサテライト(愛知県)、藤田メンタルケアサテライト徳重北(愛知県)、仁大病院(愛知県)、聖十字病院(岐阜県)、刈谷病院(愛知県)、もりやま総合心療病院(愛知県)


Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 06 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

Case registration was difficult.

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

Terminated

Date of protocol fixation

2018 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 03 Day

Last modified on

2019 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038088


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name