major depressive disorder
Conditions
Interventions
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 treatm
12) (Baseline HAM-D or CES-D) Subject who can understand and sign written informed consent by his/her own free will
Sponsors
Tokyo Womens Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of switching from duloxetine to sertraline using CGI-I, HAM-D, patient rating scales (CES-D) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakahashi hitoshi
Tokyo Womens Medical University Department of Psychiatry
Outcome results
None listed