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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048075
Receipt No. R000054795
Scientific Title To investigate clinical significance of plasma clozapine concentrations and cytokine levels.
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/16

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Basic information
Public title To investigate efficacy and safety of clozapine treatment for schizophrenia focusing on plasma clozapine concentrations and cytokine levels.
Acronym Efficacy and safety of clozapine treatment and plasma clozapine concentrations and cytokine levels
Scientific Title To investigate clinical significance of plasma clozapine concentrations and cytokine levels.
Scientific Title:Acronym Clinical significance of plasma clozapine concentrations and cytokine levels
Region
Japan

Condition
Condition Psychiatric disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate efficacy and safety of clozapine treatment for schizophrenia focusing on plasma clozapine concentrations and cytokine levels.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sequential changes regarding plasma clozapine concentrations and cytokine levels after administration of clozapine
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Subjects include patients who receive clozapine treatment for the first time from June 2022 at Kusatsu Hospital, Hiroshima, Japan.
Key exclusion criteria If informed consent is not available.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name MASARU
Middle name
Last name NAKAMURA
Organization Kosekai-Kusatsu Hospital
Division name Internal Medicine
Zip code 7330864
Address 10-1, Kusatsu-Umegadai, Nishi Ward, Hiroshima City
TEL 0822771001
Email smile1012nakamura@nifty.com

Public contact
Name of contact person
1st name MASARU
Middle name
Last name NAKAMURA
Organization Kosekai-Kusatsu Hospital
Division name Internal Medicine
Zip code 7330864
Address 10-1, Kusatsu-Umegadai, Nishi Ward, Hiroshima City
TEL 0822771001
Homepage URL
Email smile1012nakamura@nifty.com

Sponsor
Institute Kosekai-Kusatsu Hospital
Institute
Department

Funding Source
Organization None
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 Kosekai-Kusatsu Hospital
Address 10-1, Kusatsu-Umegadai, Nishi Ward, Hiroshima City
Tel 0822771001
Email smile1012nakamura@nifty.com

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
2022 Year 06 Month 17 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
2022 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 17 Day
Last follow-up date
2024 Year 06 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not particular

Management information
Registered date
2022 Year 06 Month 16 Day
Last modified on
2022 Year 06 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054795

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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