UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045819 |
|---|---|
| Receipt number | R000052310 |
| Scientific Title | Biological Psychiatry Study in Depressive Symptoms Associated with Heart Failure |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/04/24 15:46:12 |
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Basic information
Public title
Biological Psychiatry Study in Depressive Symptoms Associated with Heart Failure
Acronym
Biological Psychiatry Study in Depressive Symptoms Associated with Heart Failure
Scientific Title
Biological Psychiatry Study in Depressive Symptoms Associated with Heart Failure
Scientific Title:Acronym
Biological Psychiatry Study in Depressive Symptoms Associated with Heart Failure
Region
| Japan |
Condition
Condition
Depression, Heart Failure
Classification by specialty
| Cardiology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To evaluate the involvement of abnormalities in the kynurenic pathway in clinical practice and to elucidate the biological basis of pathology-specific depression in heart failure.
2) To evaluate the applicability of existing predictive markers to heart failure patients in order to establish a highly accurate method for early detection of depression.
Basic objectives2
Others
Basic objectives -Others
Identification of biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between PHQ-9 scores and blood levels of various substances (tryptophan, kynurenine, kynurenic acid, quinolinic acid) and various (CIDEC, RNASE1, SLC36A1, STYXL1) mRNA expression levels
Key secondary outcomes
1) Correlation between PHQ-9 score and severity of heart failure
2) Correlation between PHQ-9 score and duration of heart failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who are 20 years of age or older at the time of obtaining consent
2) A person who, after receiving sufficient explanation and understanding, has given written consent of his or her own free will to participate in this research
Key exclusion criteria
1) Patients with serious (systemic or local) infections
2) Patients who are considered to be easily infected due to serious underlying diseases or reduced immunocompetence
3) Patients with severe cognitive impairment
4) Other patients who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Kusumi |
Organization
Hokkaido University
Division name
Department of psychiatry, graduate school of medical science
Zip code
060-8648
Address
Kita 14-jo Nishi 5, Kita-ku, Sapporo City, Hokkaido
TEL
011-706-5160
ikusumi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Isoyama |
Organization
Hokkaido University
Division name
Department of psychiatry, graduate school of medical science
Zip code
060-8648
Address
Kita 14-jo Nishi 5, Kita-ku, Sapporo City, Hokkaido
TEL
011-706-5160
Homepage URL
tgo82301@elms.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14-jo Nishi 5, Kita-ku, Sapporo City, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items will be surveyed, and the data will be used for this study.
1) Basic information of the study subjects: age, sex, duration of illness, severity
of heart failure (New York Heart Association (NYHA) classification)
2) Assessment of depression using a self-administered questionnaire(one time): PHQ-9 (Patient Health Questionnaire-9)
3) Blood biochemical tests(one time): tryptophan, kynurenine, kynurenic acid, quinolinic acid, mRNA(CIDEC, RNASE1, SLC36A1, STYXL1)
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052310
