Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
Information source: Ministry of Health & Welfare, Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: 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 (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Ministry of Health & Welfare, Korea Official(s) and/or principal investigator(s): Tae-Youn Jun, MD, PhD, Study Chair, Affiliation: Clinical research center for depression
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.
Clinical Details
Official title: A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Hamilton Depression Rating Scale
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of non-psychotic Major depressive disorder
- HAMD-17 score 14 or greater
Locations and Contacts
Clinical research center for depression, Seoul 150713, Korea, Republic of
Additional Information
Starting date: May 2009
Last updated: June 23, 2009
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