UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050395 |
|---|---|
| Receipt number | R000057384 |
| Scientific Title | Association of immunological response with the presence or absence of oral mood stabilizers in schizophrenia patients infected with COVID-19. |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/02/21 13:19:41 |
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Basic information
Public title
Association of immunological response with the presence or absence of oral mood stabilizers in schizophrenia patients infected with COVID-19
Acronym
Association of immunological response with the presence or absence of oral mood stabilizers in schizophrenia patients infected with COVID-19
Scientific Title
Association of immunological response with the presence or absence of oral mood stabilizers in schizophrenia patients infected with COVID-19.
Scientific Title:Acronym
Association of immunological response with the presence or absence of oral mood stabilizers in schizophrenia patients infected with COVID-19.
Region
| Japan |
Condition
Condition
Patients with schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how oral mood stabilizers affect the immune response in schizophrenia patients infected with COVID19.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IL-6 changes after COVID-19 infection
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
Patients with chronic phase schizophrenia infected with COVID-19 during hospitalization in a psychiatric hospital
Key exclusion criteria
Comorbidity of significant physical illness
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano, Japan
TEL
026-226-1311
20hm122h@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano City
TEL
026-226-1311
Homepage URL
20hm122h@shinshu-u.ac.jp
Sponsor or person
Institute
Kurita hospital
Institute
Department
Personal name
Funding Source
Organization
Kurita hospital
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
Kurita hospital
Address
695 Kurita, Nagano City
Tel
026-226-1311
20hm122h@shinshu-u.ac.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 | 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
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe the association between the time course of immune-related substances such as IL-6 and oral administration of mood stabilizers.
Management information
Registered date
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057384
