drugset / Trial / NCT00926835

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

NCT00926835 ↗

Phase 4 Terminated 692 enrolled Ministry of Health & Welfare, Korea
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2009-05
Primary completion
2015-05
Completion
2015-07

Outcome

Outcome not reported

Stopped (Enrollment): “due to patient recruitment difficulties”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 5 mg —
Comparator Aripiprazole Other / unclassified 15 mg —
Comparator Bupropion Small molecule 150 mg —
Comparator Bupropion Small molecule 400 mg —
Comparator Escitalopram Small molecule 10 mg —
Comparator Escitalopram Small molecule 20 mg —
Comparator Lamotrigine Small molecule 100 mg —
Comparator Lamotrigine Small molecule 400 mg —
Comparator Lithium Unknown 0.5 meq —
Comparator Lithium Unknown 1.2 meq —
Comparator Mirtazapine Other / unclassified 15 mg —
Comparator Mirtazapine Other / unclassified 45 mg —
Subject Paroxetine Small molecule 20 mg —
Subject Paroxetine Small molecule 50 mg —
Comparator Venlafaxine Small molecule 75 mg —
Comparator Venlafaxine Small molecule 225 mg —