UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021800 |
|---|---|
| Receipt number | R000025140 |
| Scientific Title | Comparison of atypical antipsychotics for recovery in schizophrenia |
| Date of disclosure of the study information | 2016/05/05 |
| Last modified on | 2017/12/05 11:11:56 |
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Basic information
Public title
Comparison of atypical antipsychotics for recovery in schizophrenia
Acronym
CARS study
Scientific Title
Comparison of atypical antipsychotics for recovery in schizophrenia
Scientific Title:Acronym
CARS study
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
A 52-week randomized open-label study of asenapine, olanzapine and blonanserin in the treatment of Japanese schizophrenia patients: data from neurocognitive function, social function and decision making.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in PANSS scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
asenapine
Interventions/Control_2
olanzapine
Interventions/Control_3
blonanserin
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for primary diagnosis of schizophrenia
obtein the patient's informed consent using some documents
who can be treated following the protocol
Key exclusion criteria
treatment resistant schizophrenia
suffering from a potentially deadly disease
history of convulsive disorders such as epilepsy, or organic brain syndrome
parkinson's disease
diabetes
history of neuroleptic malignant syndrome
history of substance abuse
pregnancy or breastfeeding women
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyokazu Atake |
Organization
University of Occupational and Environmental Health
Division name
department of psyciatry, school of medecine
Zip code
Address
1-1, iseigaoka, yahatanishi-ku, kitakyusyu
TEL
093-691-7253
k-atake@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Beppu |
Organization
University of Occupational and Environmental Health
Division name
department of psyciatry, school of medecine
Zip code
Address
1-1, iseigaoka, yahatanishi-ku, kitakyusyu
TEL
093-691-7253
Homepage URL
hirokibeppu@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, School of medicine, department of psychiatry
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, School of medicine, department of psychiatry
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
| 2016 | Year | 05 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2017 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025140
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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