A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 692
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of non-psychotic Major depressive disorder
- •HAMD-17 score 14 or greater
- •Age of 18 or greater and 65 or less
排除标准
- •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.
研究组 & 干预措施
Paroxetine
Paroxetine monotherapy
干预措施: paroxetine (Drug)
Escitalopram
Escitalopram monotherapy
干预措施: Escitalopram (Drug)
Venlafaxine
Venlafaxine monotherapy
干预措施: Venlafaxine XR (Drug)
Paroxetine+Bupropion
干预措施: Paroxetine+Bupropion (Drug)
Paroxetine+Lamotrigine
干预措施: Paroxetine+Lamotrigine (Drug)
Paroxetine+Lithium
干预措施: Paroxetine+Lithium (Drug)
escitalopram+mirtazapine
干预措施: Escitalopram+Mirtazapine (Drug)
Escitalopram+Aripiprazole
干预措施: Escitalopram+Aripiprazole (Drug)
Paroxetine + Venlafaxine
干预措施: Paroxetine + Venlafaxine XR (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 6 week
次要结局
未报告次要终点
研究者
Jun Tae-Youn
Professor
The Catholic University of Korea
