UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001650 |
|---|---|
| Receipt number | R000001988 |
| Scientific Title | A prospective,multicenter, randomized, parallel-group,open-label study of aripiprazole in the management of patients with schizophrenia |
| Date of disclosure of the study information | 2009/01/22 |
| Last modified on | 2019/02/28 16:51:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective,multicenter,
randomized,
parallel-group,open-label study of
aripiprazole in the management of
patients with schizophrenia
Acronym
Chiba Broad Effectiveness Trial With
Aripiprazole (Chiba-BETA)
Scientific Title
A prospective,multicenter,
randomized,
parallel-group,open-label study of
aripiprazole in the management of
patients with schizophrenia
Scientific Title:Acronym
Chiba Broad Effectiveness Trial With
Aripiprazole (Chiba-BETA)
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to evaluate
The overall effectiveness of
aripiprazole in patients with
schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preference of Medicine(POM)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aripiprazole
Interventions/Control_2
Standard control
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
With a diagnosis of schizophrenia and noticed as schizophrenia.
Outpatients.
Taking a certain antipsychotic four weeks long.
A switch from current antipsychotic medicine was judged clinically reasonable.
Key exclusion criteria
Pregnant or breastfeeding women.
Not noticed as schizophrenia.
With diabetes.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2148
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomihisa Niitsu |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2148
Homepage URL
niitsu@chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001988
