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临床试验/ACTRN12617000527369
ACTRN12617000527369终止4 期

Effect of addition of anti-inflammatory medication to anti-depressant medication on C-reactive protein levels in the treatment of depression

Professor Bernhard Baune0 个研究点目标入组 122 人开始时间: 2017年4月11日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
入组人数
122

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 75 Years(—)
性别
All

入选标准

  • 1. The study participant is willing and able to provide informed consent.
  • 2. Age 18 – 75 years of age.
  • 3. Diagnosis of a Major Depressive Episode (MDE) as part of Major Depressive Disorder (MDD), using DSM-5 criteria.
  • 4. Montgomery Asberg Depression Rating Scale (MADRS) score greater than or equal to 26 at screening visit and baseline.
  • 5. Duration of the current MDE is at least 3 months.
  • 6. Use of a previous treatment in at least one prior episode of depression

排除标准

  • 1. Presence of a co-morbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • 2. A known relevant inflammatory or immune-related disorder such as rheumatoid arthritis, colitis, clinically significant asthma, multiple sclerosis, SLE, acute infections or fever.
  • 3. A known neurodegenerative disease
  • 4. Any medication for a general medical disorder that may affect cognitive function
  • 5. Electroconvulsive therapy (ECT) within the last 6 months.
  • 6. The study participant has reported having received investigational agents as part of a separate study within 30 days of the screening visit.
  • 7. Contraindications to the study drugs

研究者

发起方
Professor Bernhard Baune

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