UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005320 |
|---|---|
| Receipt number | R000006310 |
| Scientific Title | Exploratory observation study of biological markers for prognostic prediction and symptomatic improvement in patients at depressive state |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2022/04/04 22:03:35 |
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Basic information
Public title
Exploratory observation study of biological markers for prognostic prediction and symptomatic improvement in patients at depressive state
Acronym
Exploratory observation study of biological markers for prognostic prediction and symptomatic improvement in patients at depressive state
Scientific Title
Exploratory observation study of biological markers for prognostic prediction and symptomatic improvement in patients at depressive state
Scientific Title:Acronym
Exploratory observation study of biological markers for prognostic prediction and symptomatic improvement in patients at depressive state
Region
| Japan |
Condition
Condition
Patients diagnosed with any depressive disorders based on DSM-IV-TR about 1.5 years ago
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
prognostic prediction of overt manic episode and treatment resistance by biological markers
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relation between an emergence of manic episode and biological data (e.g., findings from near infrared spectroscopy and physiological active substances) in the past
Key secondary outcomes
1. The temporal relation between clinical symptoms and biomarkers
2. The relation between the subtype of depression (e.g., treatment-resistant, or atypical/melancholic) and prognosis
3. The relation between severity of manic episode and biological markers
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. diagnosed with any depressive disorders based on DSM-IV-TR in an initial consultation about 1.5 years ago.
2. gave written informed consent to the ethical committee of each site, according to the Declaration of Helsinki after having been given a complete explanation of this study.
Key exclusion criteria
1. unable to have sufficient communication in Japanese.
2. regarded as inappropriate by the physician in charge for any other reason.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kiyoto |
| Middle name | |
| Last name | Kasai |
Organization
the University of Tokyo
Division name
Department of Neuropsychiatry, Graduate School of Medicine
Zip code
113-8655
Address
South Clinical Research Bldg., University Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
+81-3-3815-5411
kasaik-tky@umin.net
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Satomura |
Organization
the University of Tokyo
Division name
Department of Neuropsychiatry, Graduate School of Medicine
Zip code
113-8655
Address
South Clinical Research Bldg., University Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
+81-3-3815-5411
Homepage URL
ys99041@gmail.com
Sponsor or person
Institute
Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants, Research on Psychiatric and Neurological Diseases and Mental Health, H20-kokoro-ippan-001, and others.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Faculty of Medicine, University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
Tel
+81-3-5841-3557
liaison@m.u-tokyo.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
東京大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 25 | 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
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 01 | Day |
Other
Other related information
Prospective observation study
Management information
Registered date
| 2011 | Year | 03 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006310
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| Registered date | File name |
| Research case data | |
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