Strategic Use of New Generation Antidepressants for Depression
Lead SponsorKyoto University
StatusCompleted No Results Posted
Indication/ConditionUnipolar Major Depressive Episode
Intervention/Treatmentsertraline mirtazapine ...
The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Augment with or switch to mirtazapine 15-45 mg/d
Continue sertraline at the dosage at 3 weeks
Add mirtazapine to sertraline
Stop sertraline and switch to mirtazapine
Inclusion Criteria: non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition [DSM-IV]) in the preceding month age 25-75 starting treatment with sertraline clinically indicated tolerability to sertraline 25 mg/d ascertained can understand and sign informed consent form can be contacted by telephone for symptom severity and adverse events Exclusion Criteria: have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month history of schizophrenia, schizoaffective disorder or bipolar disorder current dementia, borderline personality disorder, eating disorder or substance dependence physical disease interfering with sertraline or mirtazapine treatment allergy to sertraline or mirtazapine terminal physical illness currently pregnant or breast-feeding high risk of imminent suicide requiring compulsory admission expected to change doctors within 6 months cohabiting relatives of research staff cannot understand Japanese