UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050711 |
|---|---|
| Receipt number | R000057777 |
| Scientific Title | The relationship between depression and work productivity in the patients with schizophrenia: an observational study |
| Date of disclosure of the study information | 2023/03/29 |
| Last modified on | 2023/11/01 10:43:49 |
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Basic information
Public title
The relationship between depression and work productivity in the patients with schizophrenia: an observational study
Acronym
The relationship between depression and work productivity in the patients with schizophrenia: an observational study
Scientific Title
The relationship between depression and work productivity in the patients with schizophrenia: an observational study
Scientific Title:Acronym
The relationship between depression and work productivity in the patients with schizophrenia: an observational study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between depression and presenteeism in patients with schizophrenia
Basic objectives2
Others
Basic objectives -Others
To assess the relationship between depression and presenteeism in patients with schizophrenia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change from baseline in PHQ-9 score and presenteeism (WPAI)
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Out-patients with schizophrenia at baseline
2) Patients aged 20 and over, and less than 60 years
3) Patients who have joined the health insurance
4) Patients who are able to respond in the web-basis
5) Patients who agree with the ICF
Key exclusion criteria
Not applicable
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nemoto |
Organization
Toho University Faculty of Medicine
Division name
Department of Neuropsychiatry
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
takahiro.nemoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Kinoshita |
Organization
QLife, Inc.
Division name
Study Innovation Group, Patient Recruitment Division
Zip code
105-0001
Address
Mori Building 10F, Toranomon 33, 3-8-21, Toranomon, Minato-Ku, Tokyo
TEL
0120-37-4089
Homepage URL
clinical-research-dmq22@m3.com
Sponsor or person
Institute
Sumitomo Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Pharma 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
Ethics Committee of Toho University Omori Medical Center
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541
Tel
03-5763-6534
omori.rinri@ext.toho-u.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
| 2023 | Year | 03 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the relationship between depression and work productivity in patients with schizophrenia
Management information
Registered date
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057777
| Research Plan | |
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| 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 |
