UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059289 |
|---|---|
| Receipt number | R000067816 |
| Scientific Title | the efficacy of antiviral hepatitis therapy on psychiatric symptoms in psychiatric disorders complicated by viral hepatitis. |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/04 14:09:07 |
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Basic information
Public title
the efficacy of antiviral hepatitis therapy on psychiatric symptoms in psychiatric disorders complicated by viral hepatitis.
Acronym
the efficacy of antiviral hepatitis therapy on psychiatric symptoms.
Scientific Title
the efficacy of antiviral hepatitis therapy on psychiatric symptoms in psychiatric disorders complicated by viral hepatitis.
Scientific Title:Acronym
the efficacy of antiviral hepatitis therapy on psychiatric symptoms.
Region
| Japan |
Condition
Condition
depression, schizophrenia, bipolar disorder, dementia with HCV or HBV infection
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine whether antiviral therapy for hepatitis in patients with psychiatric disorders who also have infection with HCV or HBV leads to improvement of psychiatric symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychiatric symptoms are assessed within one month before the beginning of the anti-viral therapy and 3 months after. depression: MADRS, HADS-A or HADS-D, schizophrenia: SOFA or SCGI-SCH, bipolar disorder: YMRS, dementia: MMSE
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients or inpatients diagnosed with depression, schizophrenia, bipolar disorder, or dementia, who have infection with HCV or HBV, who meet the indication for antiviral therapy, and who wish to receive it. Those who, after sufficient explanation and full understanding, give their written consent voluntarily.
Key exclusion criteria
Those for whom it is judged difficult to assess psychiatric symptoms before and after antiviral therapy. Those whom the principal investigator deems inappropriate as subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka Psychiatric Medica Center
Division name
Department of Medical Affairs
Zip code
573-0022
Address
3-16-21 Miyanosaka, Hirakata City, Osaka Prefecture, Japan
TEL
0728473261
apple-123-grape@ab.auone-net.jp
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka Psychiatric Medical Center
Division name
Department of Medical Affairs
Zip code
573-0022
Address
3-16-21 Miyanosaka, Hirakata City, Osaka Prefecture, Japan
TEL
0728473261
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka Psychiatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Psychiatric Medical Center
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
Osaka Psychiatric Medical Center
Address
3-16-21 Miyanosaka, Hirakata City, Osaka Prefecture, Japan
Tel
0728473261
apple-123-grape@ab.auone-net.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
| 2025 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In patients with psychiatric disorders infected with HCV or HBV, anti-viral hepatitis treatment will be administered, and the degree of improvement in psychiatric symptoms will be assessed before and after treatment.
Management information
Registered date
| 2025 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067816
