Study Stopped
due to patient recruitment difficulties
Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients
1 other identifier
interventional
692
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started May 2009
Longer than P75 for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 2, 2015
September 1, 2015
6 years
June 23, 2009
September 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale
6 week
Study Arms (9)
Paroxetine
EXPERIMENTALParoxetine monotherapy
Escitalopram
ACTIVE COMPARATOREscitalopram monotherapy
Venlafaxine
ACTIVE COMPARATORVenlafaxine monotherapy
Paroxetine+Bupropion
ACTIVE COMPARATORParoxetine+Lamotrigine
ACTIVE COMPARATORParoxetine+Lithium
ACTIVE COMPARATORescitalopram+mirtazapine
ACTIVE COMPARATOREscitalopram+Aripiprazole
ACTIVE COMPARATORParoxetine + Venlafaxine
ACTIVE COMPARATORInterventions
paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks
Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of non-psychotic Major depressive disorder
- HAMD-17 score 14 or greater
- Age of 18 or greater and 65 or less
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical research center for depression
Seoul, Seoul, 150713, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tae-Youn Jun, MD, PhD
Clinical research center for depression
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 24, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2015
Study Completion
July 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-09