Unipolar Major Depressive Episode | Strategic Use of New Generation Antidepressants for Depression

Unipolar Major Depressive Episode research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Unipolar Major Depressive Episode

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SertralineSertraline 50 mg/d or 100 mg/d for 6 more weeks

Drug:MirtazapineAugment with or switch to mirtazapine 15-45 mg/d

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Continue sertralineContinue sertraline at the dosage at 3 weeks

Augment with mirtazapineAdd mirtazapine to sertraline

Switch to mirtazapineStop sertraline and switch to mirtazapine

Study Status


Start Date: December 2010

Completed Date: December 2015

Phase: Phase 4

Type: Interventional


Primary Outcome: Observer-rated depression severity (PHQ-9)

Secondary Outcome: Self-rated depression severity (BDI-II)

Study sponsors, principal investigator, and references

Principal Investigator: Toshiaki A Furukawa, MD, PhD

Lead Sponsor: Kyoto University

Collaborator: National Center of Neurology and Psychiatry, Japan

More information:

Discuss Mirtazapine