Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis
详细描述
The prevalence of insulin resistance did not significantly differ among the healthy controls and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current study indicated that antidepressants might affect insulin secretion independently of the therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness and glucose-insulin homeostasis in MDD patients are necessary.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 16-65 years old
- •Signed informed consent by patient or legal representative
- •Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
- •A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry
排除标准
- •Monoamine oxidase inhibitor or antidepressant treatment prior to entering the study
- •A DSM-IV diagnosis of substance abuse within the past three months
- •An organic mental disease, mental retardation or dementia
- •A serious surgical condition or physical illness
- •Patients who were pregnant or breastfeeding
研究组 & 干预措施
Fluoxetine + Valsartan
The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.
Add-on treatment to 40 mg per day of valsartan
干预措施: Fluoxetine + Valsartan (Drug)
Fluoxetine + Placebo
The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.
Add-on treatment to placebo
干预措施: Fluoxetine + Placebo (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: 12 weeks
次要结局
- fasting serum insulin(12 weeks)
- fasting plasma glucose(12 weeks)
- C-reactive Protein, and IL-6(12 weeks)
研究者
Po-See, Chen
Associate Professor
National Cheng-Kung University Hospital