EUCTR2017-004829-33-ES进行中（未招募）1 期
Interventional, open-label, flexible-dose study of vortioxetine on emotional functioning in patients with major depressive disorder with inadequate response to SSRI/SNRI treatment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 151
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patient has a primary diagnosis of single or recurrent MDD according
- •to DSM-5®. The current major depressive episode (MDE) must be
- •confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has had the current MDE for <12 months.
- •The patient has a Montgomery and Åsberg Depression Rating Scale
- •(MADRS) total score = 22 and = 28 at the Baseline Visit.
- •The patient has been treated with SSRI/SNRI monotherapy (citalopram,
- •escitalopram, paroxetine, duloxetine or venlafaxine) for at least 6 weeks at
- •adequate dose for the current MDE and with an inadequate response and
- •is a candidate for a switch in the investigator’s opinion.
- •The patient wants to switch antidepressant treatment.
- •The patient has an ODQ total score =50 at baseline, while on SSRI/SNRI
- •monotherapy (prior to switch).
- •The patient answered Yes to the screening question on emotional effects.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient has a significant risk of suicide according to the investigator’s
- •clinical judgment or has made an actual suicide attempt in the previous 6
- •months prior to Baseline
研究者
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