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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005320
Receipt No. 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 2017/10/09

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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
Middle name
Last name Kiyoto Kasai
Organization the University of Tokyo
Division name Department of Neuropsychiatry, Graduate School of Medicine
Zip code
Address South Clinical Research Bldg., University Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL +81-3-3815-5411
Email kasaik-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Satomura
Organization the University of Tokyo
Division name Department of Neuropsychiatry, Graduate School of Medicine
Zip code
Address South Clinical Research Bldg., University Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL +81-3-3815-5411
Homepage URL
Email ys99041@gmail.com

Sponsor
Institute Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
Institute
Department

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
Address
Tel
Email

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
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
2017 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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