Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- • The primary endpoint is the change in Hamilton Rating Scale
研究概览
简要总结
Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with a Hamilton rating score of more than 18.
排除标准
- •Patients with bipolar I or bipolar II disorder
- •Patients with personality disorders
- •Patients with eating disorders
- •Patients with substance dependence or abuse
- •Patients with concurrent active medical conditions
- •Patients with a history of seizures
- •Patients with a history of receiving Electroconvulsive therapy (ECT)
- •Patients with inflammatory disorders
- •Patients with allergies or contraindications to the used medications
- •Patients with finally pregnant or lactating females
- •Diabetic or hyperlipidaemic patients
研究组 & 干预措施
Control Group
Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months
干预措施: Fluoxetine 20 mg (Drug)
Dapagliflozin group
Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
干预措施: Fluoxetine 20 mg (Drug)
Dapagliflozin group
Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
干预措施: Dapagliflozin 10mg Tab (Drug)
Atorvastatin group
Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
干预措施: Fluoxetine 20 mg (Drug)
Atorvastatin group
Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
干预措施: Atorvastatin 80mg (Drug)
结局指标
主要结局
• The primary endpoint is the change in Hamilton Rating Scale
时间窗: 3 months
• The primary endpoint is the change in Hamilton Rating Scale
次要结局
- The secondary endpoint is estimated by changes in serum biomarkers.(3 months)
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University