UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042118 |
|---|---|
| Receipt number | R000048069 |
| Scientific Title | Relationship between the pathogenesis of treatment-resistant depression and brain beta-amyloid: an exploratory study by measuring trace beta-amyloid levels in plasma |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/10/14 15:25:51 |
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Basic information
Public title
Relationship between the pathogenesis of treatment-resistant depression and brain beta-amyloid: an exploratory study by measuring trace beta-amyloid levels in plasma
Acronym
Relationship between the pathogenesis of treatment-resistant depression and brain beta-amyloid
Scientific Title
Relationship between the pathogenesis of treatment-resistant depression and brain beta-amyloid: an exploratory study by measuring trace beta-amyloid levels in plasma
Scientific Title:Acronym
Relationship between the pathogenesis of treatment-resistant depression and brain beta-amyloid
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is a basic exploratory study to explore the potential of anti-amyloid therapy for refractory depression. Brain A-beta accumulation in refractory depressed patients will be measured by quantitative plasma beta-amyloid (A-beta) assay and compared with data from age-specific healthy subjects. We will also examine the relationship between plasma A-beta and depression symptomatology and cognitive functions related to memory and organization in patients with refractory depression to determine the physiological role of A-beta in the brain of patients with depression.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in plasma A-beta40 and A-beta42 concentrations between depressed and healthy subjects
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood examinetion (plasma concentraton of beta amyloid)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for major depressive disorder (depression).
-Patients between the ages of 20 and 80 years old at the time of participation in the study
-At least one antidepressant medication in a current or past depressive episode
-Patients who do not respond to sufficient doses and duration of pharmacotherapy to meet the
Key exclusion criteria
-Patients with other comorbid psychiatric disorders
-Patients with a history of neurological or cerebral organic disorders
-Patients with serious metabolic, endocrine and other physical diseases
-Patients with significant suicidal ideation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8471
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
TEL
03-3433-1111
kodaka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8471
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
TEL
03-3433-1111
Homepage URL
kodaka@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
Tel
03-3433-1111
kodaka@jikei.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
| 2020 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2020 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048069
