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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011194
Receipt No. R000013116
Scientific Title Efficacy and tolerability of blonanserin versus aripiprazole in Japanese patients with psychotic disorder: a randomized, masked-rater trial
Date of disclosure of the study information 2013/07/16
Last modified on 2017/01/27

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Basic information
Public title Efficacy and tolerability of blonanserin versus aripiprazole in Japanese patients with psychotic disorder: a randomized, masked-rater trial
Acronym A randomized controlled trial of blonanserin versus aripiprazole in psychotic disorder
Scientific Title Efficacy and tolerability of blonanserin versus aripiprazole in Japanese patients with psychotic disorder: a randomized, masked-rater trial
Scientific Title:Acronym A randomized controlled trial of blonanserin versus aripiprazole in psychotic disorder
Region
Japan

Condition
Condition psychotic disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the therapeutic efficacy and tolerability of blonanserin and aripiprazole in patients with psychotic disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes PANSS
Key secondary outcomes CGI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
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 Blonanserin
Interventions/Control_2 Aripiprazole
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 Schizophrenia, schizoaffective disorder, schizophreniform disorder based on DSM-4-TR
The patients did not take any antisychotics for more than 2 weeks
Key exclusion criteria Patients with coma.
Patients take barbiturate, anesthetic, adrenaline, psychostimulant or.and alocohol.
Patients with allergies to blonanserin and aripiprazole
Patients who are pregnant or may become pregnant
Patients with personality disorder or mental retardation.
ients with dementina.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakao Iwata
Organization Fujita Health University School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL 0562939250
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taro Kishi
Organization Fujita Health University School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL 0562939250
Homepage URL
Email tarok@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor The Okehazama Hospital
The Jindai Hospital
The St. Cross Hospital
The Toyota Memorial Hospital
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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.dovepress.com/a-randomized-trial-of-aripiprazole-vs-blonanserin-for-the-treatment-of-pee
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
2013 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 08 Month 16 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 16 Day
Last modified on
2017 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013116

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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