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临床试验/EUCTR2011-005320-17-GB
EUCTR2011-005320-17-GB进行中(未招募)1 期

Effects of agomelatine versus escitalopram on emotional experiences in outpatients suffering from Major Depressive Disorder. An exploratory, randomised, double-blind, international, multicentre study with parallel groups: agomelatine (25 to 50 mg/day) versus escitalopram (10 to 20 mg/day) over a 6- month period.

Institut de Recherches Internationales Servier0 个研究点目标入组 398 人开始时间: 2012年3月7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
398

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

入选标准

  • - Outpatients aged between 18 (or minimum legal age) and 65 years (inclusive), fluent in English, i.e. competent in reading, writing and speaking English (except for Brazil, fluent in Portuguese)
  • - Fulfilling DSM-IV criteria for Major Depressive Disorder, single episode or recurrent (maximum 3 episodes including the current one) documented using the brief structured interview M.I.N.I.
  • 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 475
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • - Depressive episode of mild intensity according to DSM-IV TR criteria
  • - Marked suicidal intent and/or known suicidal tendencies for the current episode
  • - Women of childbearing potential without effective contraception method
  • - Pregnant or breast-feeding women
  • - Patients not able to read or to complete self-rating questionnaires
  • - All types of depression other than Major Depressive Disorder, all other psychiatric disorders

研究者

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