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

September 1, 2015 updated by: Jun Tae-Youn, Ministry of Health & Welfare, Korea

A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

692

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 150713
        • Clinical research center for depression

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paroxetine
Paroxetine monotherapy
Drug: paroxetine
6 weeks, 20-50mg/day
Other Names:
  • Seroxat
Active Comparator: Escitalopram
Escitalopram monotherapy
Drug: Escitalopram
10-20mg/day for 6 weeks
Other Names:
  • lexapro
Active Comparator: Venlafaxine
Venlafaxine monotherapy
Drug: Venlafaxine XR
Venlafaxine 75-225mg/day for 6 weeks
Other Names:
  • Efexor XR
Active Comparator: Paroxetine+Bupropion
Drug: Paroxetine+Bupropion
paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
Other Names:
  • Seroxat, wellbutrin
Active Comparator: Paroxetine+Lamotrigine
Drug: Paroxetine+Lamotrigine
Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
Other Names:
  • seroxat, lamictal
Active Comparator: Paroxetine+Lithium
Drug: Paroxetine+Lithium
Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
Other Names:
  • seroxat, lithan
Active Comparator: escitalopram+mirtazapine
Drug: Escitalopram+Mirtazapine
escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
Other Names:
  • lexapro, remeron
Active Comparator: Escitalopram+Aripiprazole
Drug: Escitalopram+Aripiprazole
escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks
Other Names:
  • lexapro, abilify
Active Comparator: Paroxetine + Venlafaxine
Drug: Paroxetine + Venlafaxine XR
Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks
Other Names:
  • seroxat, efexor XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale
Time Frame: 6 week
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health & Welfare, Korea

Investigators

  • Study Chair: Tae-Youn Jun, MD, PhD, Clinical research center for depression

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIHWAF-CRCD-K-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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