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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926835
Recruitment Status : Terminated (due to patient recruitment difficulties)
First Posted : June 24, 2009
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Jun Tae-Youn, The Catholic University of Korea

Brief 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.

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

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: 6 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of non-psychotic Major depressive disorder
  • HAMD-17 score 14 or greater
  • Age of 18 or greater and 65 or less

Exclusion Criteria:

  • patients with current or past history of diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder NOS
  • patients with current psychotic features, eating disorders or obsessive-compulsive disorder
  • patients with neurological disorder
  • patients with medical condition that could interfere with everyday life activities
  • pregnant or lactating women,
  • patients with current other DSM-IV TR Axis I diagnosis other than MDD which needs inpatient care
  • patients who treated with ECT for current depressive episode
  • insufficient information of past treatment for current depressive episode
  • patients who posed a serious suicidal risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926835

Korea, Republic of
Clinical research center for depression
Seoul, Korea, Republic of, 150713
Sponsors and Collaborators
Ministry of Health & Welfare, Korea
Study Chair: Tae-Youn Jun, MD, PhD Clinical research center for depression

Responsible Party: Jun Tae-Youn, Professor, The Catholic University of Korea Identifier: NCT00926835     History of Changes
Other Study ID Numbers: MIHWAF-CRCD-K-01
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Lithium Carbonate
Venlafaxine Hydrochloride
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents