UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048075 |
|---|---|
| Receipt number | 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 | 2022/12/16 17:49:56 |
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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
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
smile1012nakamura@nifty.com
Sponsor or person
Institute
Kosekai-Kusatsu Hospital
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
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 | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054795
