UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031422
Receipt number R000035871
Scientific Title SNP analysis of brexpiprazole-treated Japanese schizophrenia patients.
Date of disclosure of the study information 2018/02/26
Last modified on 2021/03/08 11:32:03

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Basic information

Public title

SNP analysis of brexpiprazole-treated Japanese schizophrenia patients.

Acronym

Genomics analysis-schizophrenia

Scientific Title

SNP analysis of brexpiprazole-treated Japanese schizophrenia patients.

Scientific Title:Acronym

Genomics analysis-schizophrenia

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To explore factors associated with drug response in Japanese patients with schizophrenia based on information in clinical evaluation index and genetic information collected from those patients who have attended a clinical trial(Clinical Trials. gov, NCT01451164, #331-10-002).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Factors which influence antipsychotics responses will be explored.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

65 years-old >

Gender

Male and Female

Key inclusion criteria

-Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
-Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
-Patients who are experiencing acute exacerbation of psychotic symptoms

Key exclusion criteria

-Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
-Patients presenting a first episode of schizophrenia based on the clinical judgement of the investigator
-Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis I criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Target sample size

280


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroko Komatsu

Organization

Otsuka Pharmaceutical, Co., Ltd

Division name

New Drug Research Division

Zip code


Address

Kagasuno 463-10, kawauchi-cho, Tokushima-shi, Tokushima 771-0192

TEL

088-665-2126

Email

Komatsu.Hiroko@otsuka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Komatsu

Organization

Otsuka Pharmaceutical, Co., Ltd

Division name

New Drug Research Division

Zip code


Address

Kagasuno 463-10, kawauchi-cho, Tokushima-shi, Tokushima 771-0192

TEL

088-665-2126

Homepage URL


Email

Komatsu.Hiroko@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


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



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 26 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

Completed

Date of protocol fixation

2017 Year 09 Month 05 Day

Date of IRB

2017 Year 03 Month 14 Day

Anticipated trial start date

2018 Year 02 Month 19 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

Exploration of factors associated with drug response in patients with schizophrenia based on information in clinical evaluation index and genetic information collected from those patients who have attended a clinical trial for Brexpiprazole.


Management information

Registered date

2018 Year 02 Month 22 Day

Last modified on

2021 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035871


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name