UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine
Title of the study (Brief title)	A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine
Region	Japan

Condition
Condition	major depressive disorder
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The objective of this study is to investigate the clinical response of sertraline in patients who failed treatment with duloxetine. In addition, we would like to explore the clinical, genetic, epigenetic, and metabolome factors between responders and non-responders, and between remitter and non-remitter of sertraline treatment as a possible predictors of sertraline. This prospective observational study provides the clinical implication in switching from duloxetine to sertraline for the first time as well as detecting predictors for the response of sertraline, who failed treatment with duloxetine in patients of depression.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy rate of switching from duloxetine to sertraline using CGI-I, HAM-D, patient rating scales (CES-D)
Key secondary outcomes	Epigenetic changes before and after sertraline treatment Baseline clinical, genetic, and epigenetic and metabolome factors in sertraline responders compared to those of non-responders Baseline clinical, genetic, and epigenetic and metabolome factors in sertraline remitters compared to those of non-remitters

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	Subjects fulfilled the DSM-IV criteria for major depressive disorder Men and women aged 20 or over Non-responder with duloxetine 60mg more than 6 weeks symptomatic worsening during duloxetine treatment or intolerant patients (Not achieved 50% MADRS reduction or MADRS<12) (Baseline HAM-D or CES-D) Subject who can understand and sign written informed consent by his/her own free will
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects fulfilled the DSM-IV criteria for major depressive disorder Men and women aged 20 or over Non-responder with duloxetine 60mg more than 6 weeks symptomatic worsening during duloxetine treatment or intolerant patients (not achieved 50% HAM-D reduction or HAM-D<7) Subject who can understand and sign written informed consent by his/her own free will
Key exclusion criteria	Comorbidity of alcohol and/or drug abuse Presence of psychosis Intolerant to sertraline Required prohibited concomitant therapy (to be described) Pregnant women women suspected of being pregnant or breastfeeding Serious or unstable medical illness Judged to be at risk by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Takahashi hitoshi
Organization	Tokyo Womens Medical University
Division name	Department of Psychiatry
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	0333538111
Email	takahashi.hitoshi@twmu.ac.jp

Public contact
Name of contact person	Takahashi hitoshi
Organization	Tokyo Womens Medical University
Division name	Department of Psychiatry
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	0333538111
Homepage URL
Email	takahashi.hitoshi@twmu.ac.jp

Sponsor
Institute	Tokyo Womens Medical University
Institute
Department

Funding Source
Organization	Tokyo Womens Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	東京女子医科大学病院（東京都）　Tokyo Women’s Medical University(Tokyo)

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 10 Month 23 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	All patients are treated with sertraline in a dose range from 25 mg/day to 100 mg/day after down-titration of the dose of duloxetine

Management information
Registered date	2012 Year 12 Month 21 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011270