Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
|ClinicalTrials.gov Identifier: NCT00926835|
Recruitment Status : Terminated (due to patient recruitment difficulties)
First Posted : June 24, 2009
Last Update Posted : September 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: paroxetine Drug: Escitalopram Drug: Venlafaxine XR Drug: Paroxetine+Bupropion Drug: Paroxetine+Lamotrigine Drug: Paroxetine+Lithium Drug: Escitalopram+Mirtazapine Drug: Escitalopram+Aripiprazole Drug: Paroxetine + Venlafaxine XR||Phase 4|
Patients will be classified into 3 levels by their past therapeutic histories:
Level 1: Patients who do not receive an appropriate treatment for their current major depressive episode.
Level 2: Patients who never showed a satisfactory response to an adequate dosage of Paroxetine during a sufficient period of their current major depressive episode.
Level 3: Patients without a satisfactory response to two or more antidepressants including one of Paroxetine or Escitalopram for a sufficient period.
A satisfactory response means baseline HAM-D17 score was reduced over 50% or HAM-D17 score 10 or below and a sufficient period means 6 weeks.
Patients will be randomly assigned to the following treatment groups. Patients in level 1 will be randomly assigned to treatment groups among Paroxetine monotherapy, Escitalopram monotherapy, or Venlafaxine monotherapy.
Patients in level 2 will be enrolled who were medicated Paroxetine monotherapy in level 1 and assigned to one of the following 4 groups; Escitalopram monotherapy, Venlafaxine monotherapy, Paroxetine combined with Venlafaxine, or Paroxetine augmented with Lithium.
Patients in level 3 will be randomly assigned to one of the following 4 groups: 1) Either Paroxetine combined with Lamotrigine or Paroxetine combined with Bupropion if they resist two antidepressants including Paroxetine. 2) Either Escitalopram combined with Mirtazapine or Escitalopram combined with Aripiprazole if they resist two antidepressants including Escitalopram. 3) Patients who does not respond to both Paroxetine and Escitalopram will be randomly assigned to either 1) or 2).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||692 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||July 2015|
6 weeks, 20-50mg/day
Other Name: Seroxat
Active Comparator: Escitalopram
10-20mg/day for 6 weeks
Other Name: lexapro
Active Comparator: Venlafaxine
Drug: Venlafaxine XR
Venlafaxine 75-225mg/day for 6 weeks
Other Name: Efexor XR
|Active Comparator: Paroxetine+Bupropion||
paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
Other Name: Seroxat, wellbutrin
|Active Comparator: Paroxetine+Lamotrigine||
Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
Other Name: seroxat, lamictal
|Active Comparator: Paroxetine+Lithium||
Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
Other Name: seroxat, lithan
|Active Comparator: escitalopram+mirtazapine||
escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
Other Name: lexapro, remeron
|Active Comparator: Escitalopram+Aripiprazole||
escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks
Other Name: lexapro, abilify
|Active Comparator: Paroxetine + Venlafaxine||
Drug: Paroxetine + Venlafaxine XR
Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks
Other Name: seroxat, efexor XR
- Hamilton Depression Rating Scale [ Time Frame: 6 week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926835
|Korea, Republic of|
|Clinical research center for depression|
|Seoul, Korea, Republic of, 150713|
|Study Chair:||Tae-Youn Jun, MD, PhD||Clinical research center for depression|