Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients

Summary

The primary purpose of this study is to investigate the effectiveness of antidepressants on the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides MDD patients into 3 level groups according to their past histories to treatments and compares the effectiveness of various treatment regimens at each level.

The treatment level groups are: 1) patients who have never been treated with appropriate medications for their current depressive symptoms before, 2) who received an appropriate SSRI (Selective Serotonin Reuptake Inhibitor) once but did not respond to it, 3) who received two types of SSRI antidepressant treatments without much effects in reducing their depressive symptoms.

The first level group will be treated with a single SSRI antidepressant treatment. The second and third level groups, who received SSRI treatment before, will be treated with alternative SSRI antidepressants (switching), combined multiple SSRI treatments (antidepressant combination), or SSRI treatments combined with mood stabilizer or anti-psychotics (augmentation). This study does not use placebos. Patients will visit 5 times for 6 weeks at each level for treatments. Patients will be evaluated for the severity of depressive symptoms, functional level, and side effects at each visit. Afterwards, the investigations will combine to monitor the patients depressive symptoms in every 3 months for the next 24 months. 18 nationwide university hospitals will participate in this study. This multi-site, prospective, and naturalistic study for patients with depression in Korea is a main project of 'Clinical Research Center for Depression' funded by the Ministry for Health, Welfare, and Family Affairs (MIHWAF) in Korea for a highly-qualified research achievement.

Conditions

• Major Depressive Disorder

Interventions

DRUG

paroxetine

6 weeks, 20-50mg/day

DRUG

Escitalopram

10-20mg/day for 6 weeks

DRUG

Venlafaxine XR

Venlafaxine 75-225mg/day for 6 weeks

DRUG

Paroxetine+Bupropion

paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks

DRUG

Paroxetine+Lamotrigine

Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks

DRUG

Paroxetine+Lithium

Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L

DRUG

Escitalopram+Mirtazapine

escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks

DRUG

Escitalopram+Aripiprazole

escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks

DRUG

Paroxetine + Venlafaxine XR

Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks

Sponsors & Collaborators

• Ministry of Health & Welfare, Korea

  lead OTHER_GOV

Principal Investigators

• Tae-Youn Jun, MD, PhD · Clinical research center for depression

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2015-05-31

Completion

2015-07-31

Countries

• South Korea

Study Locations