TCTR20171010002Enrolling By Invitation未知
The effect of agomelatine on sleep disturbance, depression and anxiety in patients with systemic lupus erythematosus, a randomized, double-blinded, placebo-controlled trial
/A0 个研究点目标入组 72 人开始时间: 2017年10月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Age between 18-75 years
- •2.Diagnosed with SLE according to ACR1997 criteria
- •3.Pittsburgh Sleep Quality Index (PSQI) score of more than 5 on screening day
- •4.No sign of major depression inventory
- •5.Able to communicate
排除标准
- •1.Known allergic reaction to agomelatine
- •2.Diagnosed with SLE mixed with other connective tissue disease
- •3.Treatment with medications which have drug-drug interaction to agomelatine (via CYP1A2) such as atazanavir, fluvoxamine, cimetidine, ciprofloxacin, estrogen therapy, thiabendazole, zileuton, primidone, carbamazepine and rifampicin
- •(DMPA injection or condom use together with date counting will be suggested for contraception)
- •4.Ongoing or previous medically treated depression or bipolar disorder
- •5.Active liver disease (elevation of aminotransferases of more than 3 times of upper normal limit)
- •6.Impaired Kidney function (Creatinine >2)
- •7.Known medically treated sleep disorder (receiving hypnotic medication)
- •8.Shift work/night work
- •9.Daily intake of more than 5 units of alcohol
- •10.Predicted poor compliance
- •11.Pregnant or breastfeeding
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