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
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
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
Start Date: December 2010
Completed Date: December 2015
Phase: Phase 4
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