UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055403 |
|---|---|
| Receipt number | R000062941 |
| Scientific Title | Exploratory Study of the Correlation between Intron Retention (IR) Variability and Depression Scores |
| Date of disclosure of the study information | 2024/09/03 |
| Last modified on | 2025/03/21 15:36:19 |
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Basic information
Public title
Exploratory Study of the Correlation between Intron Retention (IR) Variability and Depression Scores
Acronym
Exploratory Study on the Variability of Intron Retention (IR) with Changes in Depression Scores
Scientific Title
Exploratory Study of the Correlation between Intron Retention (IR) Variability and Depression Scores
Scientific Title:Acronym
Exploratory Study of Intron Retention (IR) Variability and Depression Scores
Region
| Japan |
Condition
Condition
Depressive symptoms
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical potential of Intron Retention (IR) variability as a biomarker for quantifying depressive symptoms in neuropsychiatric disorders using Kamikihito, a Kampo medicine applied to neuropsychiatric disorders.
Basic objectives2
Others
Basic objectives -Others
Intron Retention (IR) variability as a biomarker for quantifying depressive symptoms in neuropsychiatric disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intron Retention (IR) associated with changes in depression scores
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Taking the Kampo medicine (Kamikihito) for 2 months.
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
･Subjects aged 18-65.
･Subjects whose Beck Depression Inventory - Second Edition score are less than 28 points.
Key exclusion criteria
･Subjects undergoing depression treatment.
･Subjects who have taken Kampo medicines within the last 4 weeks.
･Subjects who have taken antibiotics within the last 4 weeks.
･Subjects who clearly need Western medical care.
･Subjects diagnosed with ulcerative colitis or Crohn's disease.
･Subjects with hepatic dysfunction or renal dysfunction.
･Subjects who participated in other clinical studies within 12 weeks before the start of study.
･Subjects judged by the attending physician to be ineligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University
Division name
School of Pharmacy
Zip code
1088641
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6238
kobayashiy@pharm.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akino |
| Middle name | |
| Last name | Wakasugi |
Organization
Kitasato University
Division name
Kitasato Institute Hospital, Department of Research
Zip code
108-8642
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL
03-5791-6346
Homepage URL
omrc-ebm@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato Institute Hospital, Research Ethics Committee
Address
5-9-1 Shirokane, Minato-ku, Tokyo, Japan
Tel
03-3444-6161
kenkyu@insti.kitasato-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
北里大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 03 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062941
