Inclusion criteria | Exclusion criteria |
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(1) The participant fulfils criteria for non-psychotic unipolar major depressive episode (DSM-IV) within 1 month before starting sertraline | 1) Having taken antidepressants, mood stabilizers (lithium, valproate, carbamazepine, lamotrigine), antipsychotics, psychostimulants (methylphenidate, pemoline, atomoxetine), electroconvulsive therapy, rTMS, light therapy, or depression-specific psychotherapies (cognitive-behaviour therapy, interpersonal therapy) within 1 month before starting sertraline |
(2) Age between 25 and 75 on the day when sertraline is started | (2) History of schizophrenia, schizoaffective disorder or bipolar disorder (DSM-IV) as judged by treating physician |
(3) The major depressive episode is the focus of the treatment and the treating physician has judged sertraline to be its appropriate first-line drug | (3) Current dementia, borderline personality disorder, eating disorder or substance dependence (DSM-IV) as judged by treating physician |
(4) Tolerability to sertaline has been ascertained after 3–16 days of treatment with sertraline 25 mg/day | (4) Physical diseases that may contraindicate treatment with sertraline or mirtazapine |
(5) The participant is able to understand and sign written informed consent | (5) Allergy to sertraline or mirtazapine |
(6) The participant is available on the phone for assessment of symptoms and side effects | (6) Terminal physical diseases |
(7) Women who are pregnant or breastfeeding (if there is a possibility of getting pregnant within 6 months of trial entry, participation is allowed only after providing signed consent to avoid pregnancy during the trial period) | |
(8) Imminent high risk of suicide as judged by treating physician | |
(9) Needing non-voluntary hospitalisation | |
(10) High probability of changing hospital due to relocation, etc., within 6 months of trial entry | |
(11) Cohabiting family members of research staff members of the trial | |
(12) Inability to understand written Japanese |