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

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 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

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

Value
https://center6.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