UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002228 |
|---|---|
| Receipt number | 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 17:51:23 |
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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
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
yasufuru@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Resarch enforcement group, Japanese Sciety of Clinical Neuropsychopharmacology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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