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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Ministry of Health & Welfare, Korea
ClinicalTrials.gov Identifier:
NCT00926835
First received: June 23, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Ministry of Health & Welfare, Korea:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Clinical diagnosis of non-psychotic Major depressive disorder
  • HAMD-17 score 14 or greater
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926835

Locations
Korea, Republic of
Clinical research center for depression
Seoul, Korea, Republic of, 150713
Sponsors and Collaborators
Ministry of Health & Welfare, Korea
Investigators
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:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antidepressive Agents
Aripiprazole
Bupropion
Citalopram
Dexetimide
Lamotrigine
Lithium
Mirtazapine
Paroxetine
Venlafaxine
Adrenergic Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Anti-Dyskinesia Agents
Anticonvulsants
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antimanic Agents
Antiparkinson Agents
Antipsychotic Agents
Autonomic Agents
Calcium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014