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临床试验/ACTRN12618000748213
ACTRN12618000748213已完成未知

Efficacy of saffron as an adjunct treatment for unremitted depression in adults: a randomised, double-blind placebo-controlled study

Murdoch University0 个研究点目标入组 160 人开始时间: 2018年5月4日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
160

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
18 Years 至 65 Years(—)
性别
All

入选标准

  • 1. Adults (male and female) aged between 18 and 65 years
  • 2. Currently taking a stable dose (at least 8 weeks) of a single pharmaceutical antidepressant (SSRI or SNRI)
  • 3. Despite antidepressant treatment, continues to suffer from mild-to-moderate depression as assessed by a validated measure
  • 4. Fluent in English
  • 5. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
  • 6. Willing and able to take prescribed placebo/saffron

排除标准

  • 1. DSM-5 diagnoses other than major depression, including but not limited to bipolar disorder, anxiety disorders, schizophrenia, psycho-organic syndromes, eating disorders, substance abuse or dependence disorders.
  • 2. At significant risk of suicide or engaging in self-harm behaviours
  • 3. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
  • 4. Suffering from major medical illness, including neurodegenerative /neuroinflammatory disorders, such as Alzheimer’s disease, stroke, Parkinson’s disease or multiple sclerosis; autoimmune disorders, diabetes, inflammatory bowel disease, COPD, etc.
  • 5. Currently taking medications including, but not limited to glucocorticoids, antibiotics, and anticoagulant medications. Use of analgesics (once a week) or contraceptive pills are permissible.
  • 6. Currently taking saffron supplements and/or other specific herbal products, including omega-3 fatty acids.
  • 7. Greater than 10-year history of depression

研究者

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