Do Antidepressants Induce Metabolic Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia
研究概览
简要总结
Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.
The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.
详细描述
Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.
The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.
Prospective 6-month naturalistic cohort study, comparing 4 classes of antidepressants (SSRIs, SNRIs, TCAs and others) to a control group (ECT and r-TMS), in 600 patients with a major depressive disorder requiring the beginning of either antidepressant or ECT/r-TMS treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 18-70
- •Current major depressive episode (Major depressive disorder) based on the MINI interview
- •HAM-D >18
- •Requiring either antidepressant treatment, either ECT or r-TMS (as assessed by the clinician)
- •Signed informed consent
排除标准
- •Bipolar disorder (DSM-IV), Psychotic disorder (DSM-IV), Substance abuse or dependence (DSM-IV)
- •Normothymic treatment
- •Antipsychotic treatment
研究组 & 干预措施
B
干预措施: Tricyclic antidepressants (Drug)
A
antidepressant versus medical dispositive
干预措施: Tricyclic antidepressants (Drug)
结局指标
主要结局
Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia
时间窗: at Months 0, 1, 3, 6
次要结局
- Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)(at Months 0, 1, 3, 6)