Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients |
- Hamilton Depression Rating Scale [ Time Frame: 6 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1205 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paroxetine
Paroxetine monotherapy
|
Drug: paroxetine
6 weeks, 20-50mg/day
Other Name: Seroxat
|
|
Active Comparator: Escitalopram
Escitalopram monotherapy
|
Drug: Escitalopram
10-20mg/day for 6 weeks
Other Name: lexapro
|
|
Active Comparator: Venlafaxine
Venlafaxine monotherapy
|
Drug: Venlafaxine XR
Venlafaxine 75-225mg/day for 6 weeks
Other Name: Efexor XR
|
| Active Comparator: Paroxetine+Bupropion |
Drug: Paroxetine+Bupropion
paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
Other Name: Seroxat, wellbutrin
|
| Active Comparator: Paroxetine+Lamotrigine |
Drug: Paroxetine+Lamotrigine
Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
Other Name: seroxat, lamictal
|
| Active Comparator: Paroxetine+Lithium |
Drug: Paroxetine+Lithium
Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
Other Name: seroxat, lithan
|
| Active Comparator: escitalopram+mirtazapine |
Drug: Escitalopram+Mirtazapine
escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
Other Name: lexapro, remeron
|
| Active Comparator: Escitalopram+Aripiprazole |
Drug: 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
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of non-psychotic Major depressive disorder
- HAMD-17 score 14 or greater
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Tae-Youn Jun, Chairman of Clinical research center for Depression, Clinical research center for Depression of Korea |
| ClinicalTrials.gov Identifier: | NCT00926835 History of Changes |
| Other Study ID Numbers: | MIHWAF-CRCD-K-01 |
| Study First Received: | June 23, 2009 |
| Last Updated: | June 23, 2009 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Antidepressive Agents Citalopram Lithium Carbonate Mirtazapine Paroxetine Venlafaxine Bupropion Dexetimide Lithium |
Lamotrigine Aripiprazole Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013