UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020735 |
|---|---|
| Receipt number | 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 | 2021/07/31 09:08:00 |
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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
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
katom@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University, Osaka, Japan
Institute
Department
Personal name
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
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
| 2023 | Year | 09 | Month | 30 | 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
| 2021 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023924
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