Strategic Use of New Generation Antidepressants for Depression

Phase 4

Completed

• Conditions: Unipolar Major Depressive Episode
• Interventions: Drug: Sertraline; Drug: Mirtazapine

• Registration Number: NCT01109693
• Lead Sponsor: Kyoto University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-12
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2011

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Augment with mirtazapine	Sertraline	Add mirtazapine to sertraline
Augment with mirtazapine	Mirtazapine	Add mirtazapine to sertraline
Switch to mirtazapine	Mirtazapine	Stop sertraline and switch to mirtazapine
Continue sertraline	Sertraline	Continue sertraline at the dosage at 3 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Nagoya City University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Kochi Medical School Hospital; 🇯🇵 Nangoku, Kochi, Japan