IRCT20100127003210N28招募中3 期
Evaluation the Effect of Agomelatine on Sleep, Anxiety, Depression, Appetite and Fatigue in Hematopoietic Stem Cells Transplant Recipients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
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
- •Patients' satisfaction to enter the study
- •Patients aged more than 18 years and less than 75 years old who are candidates for bone marrow stem cell transplantation.
- •Weight of at least 40 kg
- •Creatinine clearance = 30 mL/min due to renal elimination of drug metabolites
- •Liver enzymes (ALT, AST) less than three times the upper limit of normal
- •If the patients suffer from anxiety or depression, they are equally divided into two groups, case and control.
排除标准
- •Patients' lack of consent to enter the study
- •Pregnancy and breastfeeding
- •History of allergy to agomelatine or any of the components of the drug formulation
- •History of underlying liver, kidney, thyroid disorders and untreated anemia in patients
- •History of bipolar disorder, mania and hypomania
- •Taking drugs that affect appetite, such as vitamins of group B and zinc
- •Consumption of stimulants such as amphetamine derivatives, or consumption of narcotic drugs
- •Simultaneous use of drugs with significant interactions with agomelatine, such as rifampin, ciprofloxacin, and fluvoxamine.
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