UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041839 |
|---|---|
| Receipt number | R000047764 |
| Scientific Title | Preliminary study on validity of central rating for patients with major depressive disorder - Evaluation of the consistency between face-to-face evaluation and remote evaluation via information and communication technology - |
| Date of disclosure of the study information | 2020/09/22 |
| Last modified on | 2024/04/12 10:30:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on validity of collective rating for depression
Acronym
Collective rating for depression
Scientific Title
Preliminary study on validity of central rating for patients with major depressive disorder
- Evaluation of the consistency between face-to-face evaluation and remote evaluation via information and communication technology -
Scientific Title:Acronym
Preliminary study on validity of central rating for patients with major depressive disorder
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the consistency between central rater's evaluation via information and communication equipment vs. face-to-face rating on the Montgomery Asberg Depression Rating Scale (MADRS) in patients with major depressive disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Consistency between face-to-face MADRS evaluation (facility rating) and remote evaluation via information and communication equipment (central rating)
Key secondary outcomes
Inter-rater reliability
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed by the attending physician with DSM-5 as the first depressive episode without psychotic symptoms or recurrent major depressive disorder (whether inpatient or outpatient)
2) Those who are 20 years old or older and 65 years old or younger when consent is obtained
3) Those who can obtain written informed consent after understanding the contents of this research
Key exclusion criteria
1) Patients diagnosed with substance use disorders
2) Patients with a history of head injury accompanied by consciousness loss
3) Individuals judged unsuitable by the attending physician for carrying out the observation, evaluation, and examination prescribed in this study.
4) Individuals judged by the attending physician to worsen the original disease by participating in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomiki |
| Middle name | |
| Last name | Sumiyoshi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Preventive Intervention for Psychiatric Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-341-2711
sumiyot@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Morio |
Organization
National Center of Neurology and Psychiatry
Division name
Translational Medical Center
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-341-2711
Homepage URL
morio@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Shionogi & Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd.
Takeda Pharmaceutical Co., Ltd.
Meiji Seika Pharma Co., Ltd.
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aoyama Gakuin University
Himorogi Psychiatric Institute
Kyorin University Hospital
Keio University Hospital
Tokyo Women's Medical University Medical Center East
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.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
市ヶ谷ひもろぎクリニック（東京都）
杏林大学医学部付属病院（東京都）
慶應義塾大学病院（東京都）
東京女子医科大学東医療センター（東京都）
国立精神・神経医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38267023/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38267023/
Number of participants that the trial has enrolled
61
Results
Evaluation of the consistency between face-to-face evaluation and remote evaluation via information and communication technology was 0.886.
Results date posted
| 2022 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 24 | Day |
Baseline Characteristics
The subjects of analysis were 59 patients [51% female, 49% male, age 21-64 (average 41.6) years] who met the diagnostic criteria for DSM-V depression, and the Quick Inventory of Depressive Symptomatology (QIDS-J) score was 2-24 (10.3 on average).
Participant flow
The number of patients registered was 61, and the analysis was 59.
Adverse events
None
Outcome measures
Consistency between face-to-face MADRS evaluation (facility rating) and remote evaluation via information and communication equipment (central rating)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
To confirm the consistency between central rater's evaluation via information and communication equipment vs. face-to-face rating on the Montgomery Asberg Depression Rating Scale (MADRS) in patients with major depressive disorder.
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047764
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
