UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005025 |
|---|---|
| Receipt number | R000005975 |
| Scientific Title | Examination of treatment utility and advantage of taking medicine in which acknowledgment function improvement in patient with schizophrenia with new antipsychotic is made main axis |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2011/04/29 18:45:59 |
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Basic information
Public title
Examination of treatment utility and advantage of taking medicine in which acknowledgment function improvement in patient with schizophrenia with new antipsychotic is made main axis
Acronym
Examination of treatment utility and advantage of taking medicine in which acknowledgment function improvement in patient with schizophrenia with new antipsychotic is made main axis
Scientific Title
Examination of treatment utility and advantage of taking medicine in which acknowledgment function improvement in patient with schizophrenia with new antipsychotic is made main axis
Scientific Title:Acronym
Examination of treatment utility and advantage of taking medicine in which acknowledgment function improvement in patient with schizophrenia with new antipsychotic is made main axis
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this examination is to to validate the therapeutic effect of new antipsychotic drugs, olanzapine on cognitive function and the advantage of feelings of taking medicine in patients with
schizophrenia. After agreement with this examination from object person, drug therapy is started according to the protocol and observation is continued by using evaluation items.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
There is a possibility that the findings obtained by this examination leads to the improvement of QOL and compliance of taking medicine in patients with schizophrenia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
pharmacotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who correspond to F20 by ICD10 diagnostic criteria and agree with this examination regardless of inpatients or outpatients
Key exclusion criteria
In case of patients with diabetic mellitus is excluded because Olanzapine is contraindicated drug.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sasada Toru |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe 650-0017, Japan
TEL
078-382-6065
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
TEL
078-382-6065
Homepage URL
Sponsor or person
Institute
Department of Psychiatry,Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry,Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 03 | Month | 01 | 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
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 02 | Month | 04 | Day |
Last modified on
| 2011 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005975
| 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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