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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002228
Receipt No. R000002337
Scientific Title Treatment Alternatives for Drug-naïve Schizophrenia in Japan
Date of disclosure of the study information 2009/07/21
Last modified on 2009/07/20

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Basic information
Public title Treatment Alternatives for Drug-naïve Schizophrenia in Japan
Acronym TADS-J
Scientific Title Treatment Alternatives for Drug-naïve Schizophrenia in Japan
Scientific Title:Acronym TADS-J
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Aripiprazole is considered to be first line for treatment of schizophrenia because it is most safe among antipsychotics. However, in the case that aripiprazole is not enough, there is no information about alternative treatment. Therefore we compare atypical antipsychotics other than aripiprazole in the patients who is nonresponder to aripiprazole.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement of schizophrenia symptoms
Key secondary outcomes adverse effects

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 considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with aripiprazole for 8 weeks
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)schizophrenia and brief psychosis
2)patients with 60 points or more than 60 points
Key exclusion criteria 1)Patinets with organic illness
2)Patinets with diabetis
3)Patinets with mental ritardation
4)Patinets who have mediation histrory with antipsychotics within 1 month
5)Patinets with severe suicidal thought

Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Yasui-Furukori
Organization Graduate School of Medicine, Hirosaki University
Division name Department of Neuropsychiatry
Zip code
Address Zaifu-cho 5
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norio Yasui-Furukori
Organization Graduate School of Medicine, Hirosaki University
Division name Department of Neuropsychiatry
Zip code
Address
TEL 0172-33-5111
Homepage URL
Email yasufuru@cc.hirosaki-u.ac.jp

Sponsor
Institute Resarch enforcement group, Japanese Sciety of Clinical Neuropsychopharmacology
Institute
Department

Funding Source
Organization Japanese Sciety of Clinical Neuropsychopharmacology
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 21 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
2008 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 20 Day
Last modified on
2009 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002337

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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