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临床试验/NCT00926835
NCT00926835终止4 期

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

Ministry of Health & Welfare, Korea1 个研究点 分布在 1 个国家目标入组 692 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Paroxetine monotherapy

干预措施: paroxetine (Drug)

Escitalopram

Active Comparator

Escitalopram monotherapy

干预措施: Escitalopram (Drug)

Venlafaxine

Active Comparator

Venlafaxine monotherapy

干预措施: Venlafaxine XR (Drug)

Paroxetine+Bupropion

Active Comparator

干预措施: Paroxetine+Bupropion (Drug)

Paroxetine+Lamotrigine

Active Comparator

干预措施: Paroxetine+Lamotrigine (Drug)

Paroxetine+Lithium

Active Comparator

干预措施: Paroxetine+Lithium (Drug)

escitalopram+mirtazapine

Active Comparator

干预措施: Escitalopram+Mirtazapine (Drug)

Escitalopram+Aripiprazole

Active Comparator

干预措施: Escitalopram+Aripiprazole (Drug)

Paroxetine + Venlafaxine

Active Comparator

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

发起方
Ministry of Health & Welfare, Korea
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jun Tae-Youn

Professor

The Catholic University of Korea

研究点 (1)

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