UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055888 |
|---|---|
| Receipt number | R000063869 |
| Scientific Title | Research on exploration of blood markers related to pre-morbid adversity experiences and the development of psychiatric disorders |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/05/12 19:08:29 |
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Basic information
Public title
Research on exploration of blood markers related to pre-morbid adversity experiences and the development of psychiatric disorders
Acronym
Research on exploration of blood markers related to pre-morbid adversity experiences and the development of psychiatric disorders
Scientific Title
Research on exploration of blood markers related to pre-morbid adversity experiences and the development of psychiatric disorders
Scientific Title:Acronym
Research on exploration of blood markers related to pre-morbid adversity experiences and the development of psychiatric disorders
Region
| Japan |
Condition
Condition
schizophrenia, bipolar disorder, autism spectrum disorder, attention deficit hyperactivity disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to measure neuropeptides (oxytocin, orexin A, neurotensin, substance P, beta-endorphin, alpha-MSH) and other molecules in peripheral blood samples and verify relationships between their concentrations and clinical parameters.
Basic objectives2
Others
Basic objectives -Others
The 2nd aim is to verify the effect of adverse experiences prior to the onset of the disease on the severity of the disease and neuropeptide concentrations.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood protein concentration, disease severity, previous adverse experiences.
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
Patients:
1) Subjects are diagnosed with schizophrenia, bipolar disorder, autism spectrum disorder, or attention deficit hyperactivity disorder using DSM-5 diagnostic criteria.
2) Subjects are treated in the department of psychiatry in Chiba University Hospital (and other hospitals that participate in this research project).
3) Subjects have participated in the research project HS202405-02 Clinical Genetic Research on Neuropsychiatric Disorders (Principal Investigator: Tomihisa Niitsu.
4) Subjects are aged between 18 and 65 years old at the time of obtaining consent.
5) Subjects have been fully informed of the study and have given their written consent freely and voluntarily after sufficient understanding.
6) Subjects are Japanese.
Healthy:
1) Subjects are not diagnosed with mental illness.
2) Subjects have participated in the research project HS202405-02 Clinical Genetic Research on Neuropsychiatric Disorders (Principal Investigator: Tomihisa Niitsu.
3) Subjects are aged between 18 and 65 years old at the time of obtaining consent.
4) Subjects have been fully informed of the study and have given their written consent freely and voluntarily after sufficient understanding.
5) Subjects are Japanese.
Key exclusion criteria
The following people are not eligible for the study
1) Subjects with a history of head injury, epilepsy, or loss of consciousness (for more than 3 minutes)
2) Subjects with a serious physical illness
3) Subjects who have not been informed of their diagnosis at the time of obtaining consent
4) Subjects with comorbid clinical target diseases (schizophrenia, bipolar disorder, autism spectrum disorder, attention deficit hyperactivity disorder) and whose clinical picture cannot be said to be dominated by any one of the psychiatric disorders.
5) Subjects with imminent suicidal ideation or suicidal behaviour.
6) Subjects who are pregnant, may be pregnant, within 28 days of giving birth, or breastfeeding.
7) Any other person who is deemed by the attending physician or the principal investigator or sub-investigator to be unsuitable for the safe conduct of the study.
For healthy people, apply the items excluding 3) above.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Kanahara |
Organization
Chiba University Center for Forensic Mental Health
Division name
Division of clinical neuroscience
Zip code
2660032
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
0432227171
kanahara@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Kanahara |
Organization
Chiba University Center for Forensic Mental Health
Division name
Division of Clinical Neuroscience
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
Homepage URL
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Research ethics committee of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2024 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063869
