Dapagliflozin, an SGLT2 Inhibitor, From Oral Hypoglycemic Agent to Antidepressant Drug
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome measure was the 17-item HDRS.
研究概览
简要总结
Major depressive disorder (MDD) is currently one of the leading causes of disability and suicidal death worldwide, and despite extensive research and massive improvements in mental health, the nature of MDD remains ambiguous. Moreover, about two-thirds of MDD patients fail to optimally respond to currently available standard therapies, and many of them suffer from treatment-resistant depression
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with Hamilton rating score more than 18.
排除标准
- •Patients with bipolar I or bipolar II disorder, personality disorders, and eating disorders.
- •Patients with substance dependence or abuse Patients with history of seizures or receiving electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Diabetic patients Sever kidney disorders
研究组 & 干预措施
Control group
Control group (n =30) who will receive fluoxetine (20 mg) and placebo once daily for 3 months
干预措施: Fluoxetine (Drug)
Dapagliflozin group
Dapagliflozin group (n=30) who will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
干预措施: Fluoxetine (Drug)
Dapagliflozin group
Dapagliflozin group (n=30) who will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
The primary outcome measure was the 17-item HDRS.
时间窗: 3 months
All patients will be assessed via Hamilton Depression Rating Scale (HDRS). A HDRS score of ≤ 7 indicates remission or partial remission \[HDRS\<17 and\>7\]. Response was defined as ≥ 50% drop in the HDRS score.
次要结局
- Change in quality of life.(3 months)