Strategic Use of New Generation Antidepressants for Depression (SUN(^_^)D)

Kyoto University

Status and phase: Completed; Phase 4

Conditions: Unipolar Major Depressive Episode

Treatments: Drug: Mirtazapine; Drug: Sertraline

Study type: Interventional

Funder types: Other

Identifiers

NCT01109693

sun-d

Details and patient eligibility

About

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.

Enrollment: 2,011 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,011 participants in 3 patient groups

Continue sertraline

Active Comparator group

Description:

Continue sertraline at the dosage at 3 weeks

Treatment:

Drug: Sertraline

Augment with mirtazapine

Active Comparator group

Description:

Add mirtazapine to sertraline

Treatment:

Drug: Mirtazapine

Drug: Sertraline

Switch to mirtazapine

Active Comparator group

Description:

Stop sertraline and switch to mirtazapine

Treatment:

Drug: Mirtazapine