UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050407 |
|---|---|
| Receipt number | R000057380 |
| Scientific Title | A retrospective study on risk factors affecting liver function with clozapine |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2024/09/16 21:11:51 |
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Basic information
Public title
A retrospective study on risk factors affecting liver function with clozapine
Acronym
Effects of clozapine on liver function
Scientific Title
A retrospective study on risk factors affecting liver function with clozapine
Scientific Title:Acronym
Effects of clozapine on liver function
Region
| Japan |
Condition
Condition
treatment-resistant schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for elevated liver enzymes with clozapine
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative dose of clozapine at 4, 8, 12, 16, and 18 weeks
Key secondary outcomes
Sex,BMI,age, concomitant medications,etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who had received clozapine in NCNP
Key exclusion criteria
1) Those who with defective data
2) Those who are receiving hepatic function-improving drugs prior to taking clozapine
3) Those who have elevated levels of liver enzymes prior to taking clozapine
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ishii |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
pharmacy
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
yaku.ishii@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ishii |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
pharmacy
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
yaku.ishii@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board at National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.jp
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
| 2023 | Year | 02 | Month | 21 | 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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057380
