Comparison of Tianeptine Versus Escitalopram for the Treatment of Depression and Cognitive Impairment in Patients With Major Depressive Disorder: A Randomized, Multicenter, Open-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 6
- 主要终点
- Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline
研究概览
简要总结
The primary object of this study is to confirm the superiority of tianeptine compared to escitalopram on effects that improves subjective and objective cognitive impairments in patients suffering from major depressive disorder.
详细描述
Along with depressive symptoms, subjective and objective cognitive impairments are frequently complained by the patients with major depressive disorder. Tianeptine acts on glutamate system and is known as a promising drug for improving cognitive impairment.
The present study aims to confirm the superiority of tianeptine compared to escitalopram on effects that improves subjective and objective cognitive impairments after a 12-week treatment in patients suffering from major depressive disorder.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling DSM-IV-TR(American Psychiatric Association, 4thedition, 2000) criteria for Major Depressive Disorder diagnosis
- •The male or female patients aged more than 40 years
- •Patients able to hand in written informed consent before his/her participation in this clinical study
- •Women of childbearing potential with negative pregnancy test during screening phase and entire study period (during entire study period, able to clearly agree with effective contraception such as contraceptive pill, progesterone injection, levonorgestrel implant, estrogen ring, transdermal contraceptive agent, intra-uterine contraceptive device, sterilization operation of husband, and double contraceptive method (e.g. combination of condom, pessary, spermicide, etc. ))
- •Patients who have subjective cognitive impairment, or who have objective cognitive impairment (MMSE ≤26) without subjective cognitive impairment
- •HAM-D(17-items) total score ≥ 16
排除标准
- •Patients meeting more than one following patient characteristics
- •Patients fulfilling DSM-IV-TR current or past diagnosis of any psychiatric disorders other than major depressive disorder (i.e. manic or hypomanic episode, schizophrenia, delirium, dementia, eating disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, major depressive disorder with psychotic features, mental retardation, organic brain disorder, or psychiatric disorders due to general medical condition, according to DSM-IV-TR)
- •Patients with any substance-related disorder (excluding nicotine) within the past 12 months, as defined in DSM-IV-TR
- •Patients with a history or presence of any neurological disorders (e.g. multiple sclerosis, seizure, etc.)
- •Patients with any axis II disorder that prone to interfere with the evaluation of the study
- •Patients with a history or presence of any hypersensitivity to tianeptine, escitalopram or other drugs
- •Patients who receive formal psychotherapy (e.g. cognitive behavioral therapy, insight-oriented psychoanalysis, interpersonal therapy, etc.) and who have a plan for getting psychotherapy
- •Patients with any clinically significant abnormality (e.g. hepatic failure, renal failure, cardiovascular disorder, respiratory disorder, gastrointestinal disorder, endocrine disorder, neurological disorder, inflammatory disorder, neoplasm, metabolic disorder, etc.)
- •Patients who have abnormal ECG and a significant disease according to the investigator's judgment
- •Patients with any chronic liver or kidney disease
- •Patients with a family history of long QT syndrome
- •Patients previously not responders to tianeptine or escitalopram in the treatment of major depressive disorder
- •Patients who have a suicide risk according to the investigator's judgment
研究组 & 干预措施
Tianeptine
干预措施: Tianeptine (Drug)
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline
时间窗: followed up to 2,4,8,12 weeks from baseline
Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline
时间窗: followed up to 4,8,12 weeks from baseline
Changes in Visual Continuous Performance Test(CPT) total score from baseline
时间窗: followed up to 4,8,12 weeks from baseline
Changes in Raven Progressive Matrices(RPM) total score from baseline
时间窗: followed up to 4,8,12 weeks from baseline
次要结局
- Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline(followed to 2,4,8,12 weeks from baseline)
- Changes in Clinical Clinical Global Impression- improvement(CGI-I)(followed to 2,4,8,12 weeks from baseline)
- Change in Response Rate from baseline(followed to 12 weeks from baseline)
- Change in Mini-Mental status examination(MMSE) total score from baseline(followed to 4,8,12 weeks from baseline)
- Change in Sexual Function Scale(followed to 2,4,8,12 weeks from baseline)
- Change in Clinical Global Impression- severity(CGI-S)(followed to 2,4,8,12 weeks from baseline)
- Change in Remission Rate from baseline(followed to 12 weeks from baseline)
研究者
Bum-Hee Yu
Professor
Samsung Medical Center