UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048873 |
|---|---|
| Receipt number | R000055684 |
| Scientific Title | A Mock Simulation of A Remote/Decentralised Clinical Trial for Patients with Major Depressive Disorder in Japan |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/12/15 19:08:55 |
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Basic information
Public title
A Mock Simulation of A Remote/Decentralised Clinical Trial for Patients with Major Depressive Disorder in Japan
Acronym
A Remote/Decentralised Clinical Trial Mock Simulation for Patients with Depression
Scientific Title
A Mock Simulation of A Remote/Decentralised Clinical Trial for Patients with Major Depressive Disorder in Japan
Scientific Title:Acronym
A Remote/Decentralised Clinical Trial Mock Simulation for Patients with Depression
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify burdens and issues of a remote/decentralised clinical trial for patients living with major depressive disorder from the viewpoints of patients, physicians, and clinical research coordinators, in order to investigate the feasibility of remote/decentralised clinical trials in patients living with major depressive disorder in the digitalisation and clinical trial environment in Japan
Basic objectives2
Others
Basic objectives -Others
in order to investigate the feasibility of remote/decentralised clinical trials
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient demographics, feedback on the clinical trial plan
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria:
Patient:
1) A patient with a diagnosis of major depressive disorder
(according to the diagnostic criteria defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
2) A patient whose major depressive disorder is mild or in remission
3) A patient aged >=18 years
Investigator:
1) A physician with experience of a principal investigator conducting pharmaceutical company-sponsored clinical trials in patients with a psychiatric disorder
2) A physician with high interest in the conduct of remote/decentralised clinical trials (both as self-reported)
Person with experience of clinical research coordinator:
1) A person with experience of clinical research coordinator in a pharmaceutical company-sponsored clinical trial in patients with a psychiatric disorder
2) A person with high interest in the conduct of remote/decentralised clinical trials (both as self-reported)
Key exclusion criteria
Exclusion criteria:
Patient:
1) A patient not capable of providing consent to participate in this study or being interviewed at physician's discretion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Yagi |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Patient Engagement
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku,Tokyo, JAPAN
TEL
0364172043
nobutaka.yagi@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Yagi |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Patient Engagement
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku,Tokyo, JAPAN
TEL
0364172043
Homepage URL
nobutaka.yagi@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka, Japan
Tel
0647975660
morikawa@amc-clinic.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
| 2022 | Year | 10 | 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
| 2022 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-interventional study
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055684
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
