UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008451 |
|---|---|
| Receipt number | R000008512 |
| Scientific Title | Randomized Controlled Trial of mirtazapine vs lithium as augmentation after SSRI/SNRI failure. |
| Date of disclosure of the study information | 2012/07/17 |
| Last modified on | 2020/01/22 14:40:17 |
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Basic information
Public title
Randomized Controlled Trial of mirtazapine vs lithium as augmentation after SSRI/SNRI failure.
Acronym
Mirtazapin Effectiveness for Treatment Resistant depressION (METRION)
Scientific Title
Randomized Controlled Trial of mirtazapine vs lithium as augmentation after SSRI/SNRI failure.
Scientific Title:Acronym
Mirtazapin Effectiveness for Treatment Resistant depressION (METRION)
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare mirtazapine with lithium as augmentation after SSRI/SNRI failure in patient with major depressive disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HAM-D change after 3 months of treatment.
Remission rate.
Key secondary outcomes
Adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
Flexible dosage of mirtazapine(15-45mg) for 12 weeks.
Interventions/Control_2
lexible dosage of lithium(100-1200mg) for 12 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
| 25 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient (25 or older) with depression defined by DSN-IV whose HAM-D score are at least 18 .
Patient who took stable SSRI or SNRI therapy for 4 weeks or more.
Key exclusion criteria
Subjects with clinically significant unstable medical illness, pregnancy, a principal psychiatric diagnosis other than major depression, a history of substance abuse or dependence active within the previous 6 months, and electroconvulsive therapy within the previous 6 months were excluded.
Subjects with axis I disorder other than major depressive disorder and personality disorder was also excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | YU |
| Middle name | |
| Last name | NAKAMURA |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
0000
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
087-891-2167
chiken-b@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | MASAKI |
| Middle name | |
| Last name | KATO |
Organization
1972
Division name
Department of Neuropsychiatry
Zip code
5708506
Address
10-15, Fumizono-cho, Moriguchi City, Osaka
TEL
06-6992-1001
Homepage URL
katom@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nara Medical University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Ethics Review Committee
Address
10-15 Fumizono
Tel
0669921001
katom@takii.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
| 2012 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0022395616308263?via%3Dihub
Number of participants that the trial has enrolled
50
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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008512
