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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020735
Receipt No. R000023924
Scientific Title Randomized controlled trial to apply personalized medicine to treatment-resistant depression with mixed feature.
Date of disclosure of the study information 2016/02/14
Last modified on 2019/07/30

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Basic information
Public title Randomized controlled trial to apply personalized medicine to treatment-resistant depression with mixed feature.
Acronym Personalized medicine for treatment-REsistant depression with MIXed feature(REMIX)
Scientific Title Randomized controlled trial to apply personalized medicine to treatment-resistant depression with mixed feature.
Scientific Title:Acronym Personalized medicine for treatment-REsistant depression with MIXed feature(REMIX)
Region
Japan

Condition
Condition Treatment-resistant depression with or without mixed feature.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 DSM-5 established New category, mixed feature specifier and this can be added to either major depressive disorder or bipolar disorder .Depressive episode, with mixed features applies when full criteria are met for a current or most-recent major depressive episode. and at least three manic/hypomanic symptoms are present. So We can add this specifier to MDD, mixed feature specifier MDD,but no treatment evidence was reported at this time.
Until now we performed randomized controlled study of several antidepressant in MDD patient from the pharmacogenetic and personalized-medicine view point. At this time we would like to move on the evidence of treatment and personalized medicine of treatment-resistant depression with mixed feature.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission rate and percent change of Hamilton rating scale for depression 17 (HAM-D17)
Key secondary outcomes Cognitive function test, NEO-FFI, Home Environment Questionarie

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 switching to different antidepressants for 6 weeks.
Interventions/Control_2 aripiprazole augmentation for 6 weeks.
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
75 years-old >
Gender Male and Female
Key inclusion criteria Screening phase
Patients who meet DMS-5 criteria for major depressive disorder.
Both male and female outpatients/inpatients aged at 20-65 years.
Patients who have a HAM-D17 total score of 17 or greater.

Rater-blind RCT phase
Patients who meet DMS-5 criteria for major depressive disorder.
Both male and female outpatients/inpatients aged at 20-75 years.
Patients who have a HAM-D17 total score of 17 or greater and less than 50% improvement in HAM-D17 for the screening phase(taking stable SSRI, SNRI or mirtazapine therapy for 6 weeks.)
Key exclusion criteria Patients who meet DSM5 for significant Axis I and II disorders except major depressive disorder.
Patients who have a ECT therapy within 3 months prior to study entree.
Patients who are comatose and strongly affected by central nervous system.
Patients known to have a history or complication of allergy to aripiprazole.
Patients with a history or a complication of diabetes.
Women who are pregnant, possibly pregnant, or breast-feeding.
Patients who have been judged by the investigator to be inappropriate for inclusion in the trial for any other reasons

Patients who have been judged by the investigators to have a high risk of suicide.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Kato
Organization Kansai Medical University, Osaka, Japan
Division name Department of Neuropsychiatry
Zip code 570-8506
Address 10-15 Fumizono-cho, Moriguchi Osaka, Japan
TEL 1669921001
Email katom@takii.kmu.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Kato
Organization Kansai Medical University, Osaka, Japan
Division name Department of Neuropsychiatry
Zip code 570-8506
Address Department of Neuropsychiatry
TEL 0669921001
Homepage URL
Email katom@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University, Osaka, Japan
Institute
Department

Funding Source
Organization Ministry for Scientific Research KAKEN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Occupational and Environmental Health
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai Medical University Medical Ethics Review Committee
Address 2-3-1 Shinmachi Hirakata Osaka Japan
Tel 072-804-0101
Email kmuccr@hirakata.kmu.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
2016 Year 02 Month 14 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
2016 Year 06 Month 27 Day
Date of IRB
2016 Year 06 Month 27 Day
Anticipated trial start date
2016 Year 08 Month 20 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 26 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023924

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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