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
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