IRCT20220422054611N1招募中4 期
Evaluating The effect of fluoxetine on severity of depressive and anxiety symptoms in hemodialysis patients: a randomized, double blind, placebo controlled clinical trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
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 80 years（—）
- 性别
- All
入选标准
- •People on hemodialysis who have a score greater than or equal to 16 according to the Beck Depression Inventory II (BDI-II) criterion and who have major depression based on a structured clinical interview (based on DSM-V)
- •Age from 18 to 80 years
- •People who have been on hemodialysis for more than three months and undergo regular hemodialysis three times a week
- •No treatment with antidepressant, benzodiazepines, pregabalin or gabapentin in the previous month
- •No treatment with ECT (Electroconvulsive therapy) in the last 2 months
- •Not being treated for psychotherapy during the study
- •Written consent to participate in the study
排除标准
- •History of severe allergic reaction to fluoxetine or intolerable drug side effects
- •Hepatitis B and C and liver failure, history of seizures, uncontrolled thyroid disease, neurological diseases, history of gastrointestinal ulcer (PUD) and gastrointestinal bleeding during the last three months
- •Patients treated with psychiatric drugs as well as taking special drugs such as: warfarin, corticosteroids, triptans, tramadol, Nonsteroidal anti-inflammatory drugs
- •Moderate to severe intellectual disability
- •Patients with a history of dementia
- •Hyponatremia
- •Existence of a serious risk factor for QTc prolongation such as congenital prolonged QT syndrome, long QT history, family history of prolonged QT or sudden cardiac death, hypokalemia, hypomagnesemia, recent heart attack, bradycardia, decompensated heart failure, concomitant use of enzyme inhibitors CYP2D6, use of other QTc prolonging drugs such as metoclopramide, antipsychotics, methadone, erythromycin, fluoroquinolones, fluconazole, etc
- •Patients presented with psychotic feature and having a disorder other than depression such as bipolar disorder, schizophrenia or other psychotic disorders, panic disorder (other anxiety disorders are not excluded), personality disorders, obsessive-compulsive disorder
- •History of stimulants and hallucinogens abuse
- •Pregnant women or women who plan to become pregnant in the next few months
- •Breastfeeding
- •Patients in need of electroconvulsive therapy or in need of hospitalization in a psychiatric center (based on the evaluation and opinion of a psychiatrist)
- •There is a possibility of suicide or a serious desire to commit suicide
研究者
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