UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.
Title of the study (Brief title)	A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.
Region	Japan

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

Objectives
Narrative objectives1	To examine the efficacy and safety of milnacipran in the patients with SSRI-resistant major depresive disorder, and short- and long-term effects of switching to milnacipran on the relationship between clinical outcomes and blood molecules levels.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Exploratory examination of short- and long-term effects of switching to milnacipran on the relationship between clinical outcomes and blood molecules levels.
Key secondary outcomes	1) The rate of Response by Hamilton Depression Rating Scale (HDRS-17) 2) The rate of Remission by Hamilton Depression Rating Scale (HDRS-17) 3) The rate continuation of treatment 4) Remission and response rate by QIDS-SR 5) Social Adaptation Self-evaluation Scale (SASS). 6) Clinical Global Inpression (CGI). 7) Montogomery-Asberg Depression rating Scale (MADRS). 8) Safety 9) Neurotransmitters, Neuropeptide, and others in peripheral blood.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switching from prior SSRI (fluvoxamine, paroxetine, sertraline, or escitalopram) to milnacipran. This is a 24-week trial.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects with current DSM-IV Major Depressive Disorder 2) Written informed consent by patients and more than 19 years old, less than 75 years old 3) unremitted patients by a SSRI(paroxetine, fluvoxamine, sertraline or escitalopram) for six more weeks 4) The score of 17-item Hamilton Depression Rating Scale (HDRS) is 14 or more.
Key exclusion criteria	1) treating with selegiline hydrochloride 2) Allergy against milnacipran 3) patients with urinary retension 4) pregnant or breast-feeding women or women, who may be pregnant 5) significant risk of suicide 6) patients with dementia, bipolar or psychotic disorders, those with a primary diagnosis of obsessive-compulsive disorder or an eating disorder. 7) Patient whom examination doctor judge improper as a trial subject
Target sample size	40

Research contact person
Name of lead principal investigator	Masaomi Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-43-226-2148
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	Tasuku Hashimoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-43-226-2148
Homepage URL
Email	t-hashimoto@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Chiba University Graduate School of Medicine, Division of Psychiatry, Chiba University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	G21054
Org. issuing International ID_1	IRB committee in Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院 Chiba University Hospital（千葉県, Chiba Pref）、袖ヶ浦さつき台病院 Sodegaura Satsukidai Hospital（千葉県, Chiba Pref）、茂原神経科病院 Mobarashinkeika Hospital（千葉県, Chiba Pref）、銚子こころクリニック Choshikokoro Clinic（千葉県, Chiba Pref）

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 02 Month 15 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2012 Year 12 Month 25 Day
Date of closure to data entry	2014 Year 09 Month 01 Day
Date trial data considered complete	2014 Year 10 Month 31 Day
Date analysis concluded	2014 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.dovepress.com/milnacipran-treatment-and-potential-biomarkers-in-depressed-patients-f-pee
Results
Other related information

Management information
Registered date	2010 Year 04 Month 21 Day
Last modified on	2016 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004262