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临床试验/ACTRN12613001352796
ACTRN12613001352796已完成3 期

Youth Depression Alleviation: A randomised controlled trial of omega-3 fatty acids (fish oil) for major depressive disorder in young people (YoDA-F)

Orygen Youth Health Research Centre0 个研究点目标入组 233 人开始时间: 2013年12月11日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
233

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

  • 1) Aged 15-25 years help seeking for psychological distress.
  • 2) A score between 11 and 20 on the QIDS-A17-C at first contact with the service AND after 1 week (plus 1-5 days if the client is unable to attend earlier) at the second assessment, or at 2 subsequent (weekly) follow-up assessments.
  • 3) A diagnosis of major depressive disorder using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P).
  • 4) Written informed consent (for individuals under 18, written informed consent of at least one parent or a guardian is required).

排除标准

  • 1) Lifetime diagnosis or history of treatment for psychotic disorder or bipolar disorder or substance dependence (assessed with a brief, self-developed checklist).
  • 2) History of treatment with an antidepressant (more than four weeks during the last 12 months, upon review of medical history).
  • 3) Acute suicidal behaviour as assessed by a score of 6 on the Comprehensive Assessment of At Risk Mental States (CAARMS; item 7.3) or aggressive behaviour (score of 6 on CAARMS item 5.4).
  • 4) Depression secondary to a medical condition.
  • 5) IQ<70 as per medical history review.
  • 6) Pregnancy or lactation.
  • 7) Laboratory values more than 15% outside the normal range for bleeding parameters.
  • 8) Individuals who are taking omega-3 supplements or psychotropic medication, currently or within 8 weeks of being included in the trial, for more than 1 week continuously.
  • 9) Known allergy to omega-3s or any ingredients in the investigational product.

研究者

发起方
Orygen Youth Health Research Centre

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