Strategic Use of New Generation Antidepressants for Depression

Study Overview
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Brief Summary
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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.

Official Title
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Strategic Use of New Generation Antidepressants for Depression

Conditions
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Unipolar Major Depressive Episode

Intervention / Treatment
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* Drug: Sertraline
* Drug: Mirtazapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continue sertraline<br>Continue sertraline at the dosage at 3 weeks | Drug: Sertraline<br>* Sertraline 50 mg/d or 100 mg/d for 6 more weeks<br>|
| Active Comparator: Augment with mirtazapine<br>Add mirtazapine to sertraline | Drug: Sertraline<br>* Sertraline 50 mg/d or 100 mg/d for 6 more weeks<br>Drug: Mirtazapine<br>* Augment with or switch to mirtazapine 15-45 mg/d<br>|
| Active Comparator: Switch to mirtazapine<br>Stop sertraline and switch to mirtazapine | Drug: Mirtazapine<br>* Augment with or switch to mirtazapine 15-45 mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer-rated depression severity (PHQ-9) | Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview. | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-rated depression severity (BDI-II) | Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves. | 9 weeks | 
| Global rating of side effects (FIBSER) | FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects. | 9 weeks |