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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033616
Receipt No. R000038088
Official scientific title of the study Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/03

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Basic information
Official scientific title of the study Subjective assessment of brexpiprazole with acute schizophrenia: An open-label study
Title of the study (Brief title) 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 Masakazu Hatano
Organization Fujita health university hospital
Division name Pharmacy
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL 0562932157
Email hatanomasakazu@yahoo.co.jp

Public contact
Name of contact person Masakazu Hatano
Organization Fujita health university hospital
Division name Pharmacy
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL 0562932157
Homepage URL
Email hatanomasakazu@yahoo.co.jp

Sponsor
Institute Fujita health university
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.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


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