Overview

Strategic Use of New Generation Antidepressants for Depression

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyoto University
Collaborator:
National Center of Neurology and Psychiatry, Japan
Treatments:
Antidepressive Agents
Mianserin
Mirtazapine
Sertraline
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