Strategic Use of New Generation Antidepressants for Depression

Kyoto University2 sites in 1 country2,011 target enrollmentDecember 2010

ConditionsUnipolar Major Depressive Episode

InterventionsSertraline Mirtazapine

DrugsSertraline Mirtazapine

Overview

Phase: Phase 4
Intervention: Sertraline
Conditions: Unipolar Major Depressive Episode
Sponsor: Kyoto University
Enrollment: 2011
Locations: 2
Primary Endpoint: Observer-rated depression severity (PHQ-9)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyoto University

Responsible Party

Principal Investigator

Toshiaki A. Furukawa

Professor

Kyoto University

Eligibility 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