UMIN-CTR Clinical Trial

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
Email	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
Email	katom@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Department of Neuropsychiatry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008512