UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036739 |
|---|---|
| Receipt number | R000041857 |
| Scientific Title | Functional brain study to clarify the association between depression and suicidal related behaviors |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2023/05/17 09:11:00 |
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Basic information
Public title
Functional brain study to clarify the association between depression and impulsivity
Acronym
Functional brain study of depression and impulsivity
Scientific Title
Functional brain study to clarify the association between depression and suicidal related behaviors
Scientific Title:Acronym
Functional brain study of depression and suicidal related behaviors
Region
| Japan |
Condition
Condition
Mood disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify brain mechanism underpinning of depression, impulsivity, and suicidal related behaviors using near-infrared spectroscopy in patients with mood disorders.
Basic objectives2
Others
Basic objectives -Others
To clarify brain mechanism underpinning of depression, impulsivity, and suicidal related behaviors using near-infrared spectroscopy in patients with mood disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify risk factors of suicidal related behaviors in 24 weeks using near-infrared spectroscopy and clinical data.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Patints: To examine NIRS and clinical assessments in the baseline visit, and do clinical evaluation in 3, 6, 12, and 24 weeks
Interventions/Control_2
Healthy subjects: To examine NIRS and clinical assessments in the baseline visit, and do clinical evaluation in 3, 6, 12, and 24 weeks
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients: major depressive disorder and bipolar disorder based on DSM.
Healthy subjects: no psychiatric disorders based on clinical interview.
Key exclusion criteria
A subject with brain organic disorders, low IQ (<70), brain injury, unstable medical condition, the first-degree relatives of neurological disorders, personality disorders, or substance use disorders.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Saitama Medical University Hospital
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
TEL
049-276-1214
kmatsuo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Saitama Medical University Hospital
Division name
Psychiatry
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
TEL
049-276-1214
Homepage URL
kmatsuo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
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
Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
Tel
049-276-1354
hirb@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 17 | Day |
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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2019 | Year | 05 | Month | 14 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041857
