Unique ID issued by UMIN | UMIN000009609 |
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Receipt number | R000011270 |
Scientific Title | A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine |
Date of disclosure of the study information | 2012/12/21 |
Last modified on | 2017/12/28 09:50:41 |
A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine
A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine
A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine
A prospective observational study on the efficacy of switching to sertraline in depressive patients who failed treatment with duloxetine
Japan |
major depressive disorder
Psychiatry | Adult |
Others
YES
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Efficacy rate of switching from duloxetine to sertraline using CGI-I, HAM-D, patient rating scales (CES-D)
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Takahashi hitoshi |
Tokyo Womens Medical University
Department of Psychiatry
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
0333538111
takahashi.hitoshi@twmu.ac.jp
1st name | |
Middle name | |
Last name | Takahashi hitoshi |
Tokyo Womens Medical University
Department of Psychiatry
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
0333538111
takahashi.hitoshi@twmu.ac.jp
Tokyo Womens Medical University
Tokyo Womens Medical University
Other
NO
東京女子医科大学病院(東京都) Tokyo Women’s Medical University(Tokyo)
2012 | Year | 12 | Month | 21 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 10 | Month | 23 | Day |
2012 | Year | 12 | Month | 01 | Day |
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
2012 | Year | 12 | Month | 21 | Day |
2017 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011270
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