Trial | NCT01109693  Report issue

Official Title

Strategic Use of New Generation Antidepressants for Depression

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2011
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.
Study Started
Dec 31
2010
Primary Completion
Sep 30
2015
Study Completion
Dec 31
2015
Last Update
Oct 03
2016
Estimate

Drug Sertraline

Sertraline 50 mg/d or 100 mg/d for 6 more weeks

Drug Mirtazapine

Augment with or switch to mirtazapine 15-45 mg/d

Continue sertraline Active Comparator

Continue sertraline at the dosage at 3 weeks

Augment with mirtazapine Active Comparator

Add mirtazapine to sertraline

Switch to mirtazapine Active Comparator

Stop sertraline and switch to mirtazapine

Criteria 

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
No Results Posted