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临床试验/EUCTR2019-002704-41-EE
EUCTR2019-002704-41-EE进行中(未招募)1 期

A randomised, double-blind, parallel-group, active controlled study evaluating the efficacy of vortioxetine versus desvenlafaxine in adult patients suffering from major depressive disorder with partial response to SSRI treatment

H. Lundbeck A/S0 个研究点目标入组 600 人开始时间: 2020年3月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
600

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, diagnosed according to DSM-5®. The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • - The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score =24 at screening and baseline.
  • - The patient has had the current MDE for =3 months and < 12 months.
  • - The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE and with a partial response and is a candidate for a switch in the investigator’s opinion.
  • - The patient wants to switch antidepressant treatment.
  • Other inclusion criteria may apply.
  • 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 600
  • 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 any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
  • Other exclusion criteria may apply.

研究者

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