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临床试验/ACTRN12612001281886
ACTRN12612001281886已完成3 期

Youth Depression Alleviation: A Randomised Controlled Trial of Cognitive Behavioural Therapy with Fluoxetine or Placebo (YoDA-C)

Orygen Youth Health Research Centre0 个研究点目标入组 153 人开始时间: 2012年12月11日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
153

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
15 Years 至 25 Years(—)
性别
All

入选标准

  • Aged between 15 and 25 years inclusive:
  • Diagnosis of Major Depressive Disorder (MDD) using Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID);
  • Score on the MADRS of 20 or greater, indicating depression of at least moderate severity;
  • Ability to provide written informed consent

排除标准

  • First episode psychosis (at least one positive symptom occurring daily for at least one week, or at least three times per week if the symptom lasts for longer than one hour on each occasion);
  • Lifetime or current SCID-I diagnosis of bipolar I or II disorder;
  • Acute or unstable medical disorder that would interfere with treatment;
  • Severe disturbance such that the young person would be unable to comply with the requirements of informed consent or comply with the study protocol;
  • Current treatment with an antidepressant medication for at least 2 weeks;
  • Previous treatment with fluoxetine that was either ineffective or poorly tolerated

研究者

发起方
Orygen Youth Health Research Centre

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