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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042118
Receipt No. 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

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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
Email 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
Email kodaka@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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