UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058132 |
|---|---|
| Receipt number | R000066431 |
| Scientific Title | An exploratory clinical trial of urinary biopyrrin concentrations in psychiatric disorders |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/09 21:48:34 |
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Basic information
Public title
An exploratory clinical trial of urinary biopyrrin concentrations in psychiatric disorders
Acronym
An exploratory clinical trial of urinary biopyrrin concentrations in psychiatric disorders
Scientific Title
An exploratory clinical trial of urinary biopyrrin concentrations in psychiatric disorders
Scientific Title:Acronym
An exploratory clinical trial of urinary biopyrrin concentrations in psychiatric disorders
Region
| Japan |
Condition
Condition
Depressive disorders, bipolar disorder and related disorders, anxiety disorders, obsessive-compulsive disorder and related disorders, trauma and stress-related disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this exploratory study is to measure urinary biopyrrin concentrations in patients with psychiatric disorders and compare them with healthy subjects.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in biopyrrin levels in psychiatric disorders compared to healthy controls
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Mental disorder group]
Patients who have been diagnosed with depression, bipolar disorder and related disorders, anxiety disorder, obsessive-compulsive disorder and related disorders, or trauma and stress-related disorders in the DSM-5-TR. The presence or absence of other psychiatric disorders is not an issue. In addition, only patients who are willing to submit a urine sample for biopyrrin testing within 7 days of starting treatment for a psychiatric disorder, including at other hospitals, are eligible.
[Healthy group]
Patients who have never been diagnosed with a psychiatric disorder, whose interview results at the time of registration are below the standard value (PHQ-9 < 10 points, GAD-7 < 10 points), and who have not self-reported abnormal findings in a health check within the past year prior to registration.
Key exclusion criteria
1. Those with a history of cardiovascular or neurological disease
2. Those with a confirmed drug or alcohol dependency
3. Those who are pregnant or within one month of giving birth
4. Those currently diagnosed with kidney disease, liver cirrhosis, or malignant neoplasms
5. Others who are deemed inappropriate by a doctor at the study cooperating institution
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shozo |
| Middle name | |
| Last name | Sato |
Organization
PreMedica Inc.
Division name
Business Development Department
Zip code
1050011
Address
Terada Building 5F, 2-3-3 Shibakoen, Minato-ku, Tokyo
TEL
0357761105
shozo.sato@premedica.co.jp
Public contact
Name of contact person
| 1st name | Shozo |
| Middle name | |
| Last name | Sato |
Organization
PreMedica Inc.
Division name
Business Development Department
Zip code
1050011
Address
Terada Building 5F, 2-3-3 Shibakoen, Minato-ku, Tokyo
TEL
0357761105
Homepage URL
shozo.sato@premedica.co.jp
Sponsor or person
Institute
PreMedica Inc.
Institute
Department
Personal name
Funding Source
Organization
None
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
PreMedica Inc. ethics review committee
Address
Terada Building 5F, 2-3-3 Shibakoen, Minato-ku, Tokyo
Tel
03-5776-1105
toshiya.yamagishi@premedica.co.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 | 07 | 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
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Biopyrrin is a metabolic product produced when bilirubin removes active oxygen in the body, and is known to be excreted in urine as oxidative stress increases. In recent years, there have been several reports from Japan and overseas that urinary excretion of biopyrrin is increased in patients under extreme mental stress, suggesting the usefulness of biopyrrin as a mental stress marker. Increased urinary excretion of biopyrrin has also been reported in those called at risk mental state and in patients with mental disorders such as depression and schizophrenia.
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066431
