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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005025
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Psychiatry,Kobe University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005975

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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