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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031898
Receipt No. R000036388
Scientific Title Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Date of disclosure of the study information 2018/04/01
Last modified on 2019/06/19

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Basic information
Public title Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Acronym Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Scientific Title Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Scientific Title:Acronym Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Region
Japan North America Europe

Condition
Condition major depressive disorder
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the gaps between the ideally synthesized evidence, guideline recommendations and real-world clinical practices in the prescription of new generation antidepressants for major depression through the past three decades.
Basic objectives2 Others
Basic objectives -Others This is a meta-epidemiologic study, which compares the difference between cumulative network meta-analysis, guideline recommendations and real world prescriptions.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ranking of antidepressants based on efficacy and acceptability by means of cumulative network meta-analysis. Ranking of recommended antidepressants in main guidelines in America and Europe. Ranking of real-world prescription of antidepressants based on American database MEPS.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 Patients with major depressive disorder, adults, both sex.
Key exclusion criteria Patients with bipolar disorder and psychotic depression.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Toshi A
Middle name
Last name Furukawa
Organization Kyoto University Graduate School of Medicine
Division name Department of Health Promotion and Human Behavior, School of Public Health
Zip code 606-8501
Address Floor 2, G Buiding, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL +81-75-753-9491
Email furukawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yan
Middle name
Last name Luo
Organization Kyoto University Graduate School of Medicine
Division name Department of Health Promotion and Human Behavior, School of Public Health
Zip code 606-8501
Address Floor 2, G Buiding, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL +81-75-753-9491
Homepage URL
Email lilacluo@gmail.com

Sponsor
Institute Department of Health Promotion and Human Behavior, School of Public Health, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization JSPS Grant-in-Aid for Scientific Research (Grant Number17k19808)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Ethics Commitee
Address Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel +81-75-753-4680
Email ethcom@kuhp.kyoto-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
2018 Year 04 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information It is an epi-epidemiologic research based on cumulative network meta-analysis.

Management information
Registered date
2018 Year 03 Month 26 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036388

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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