CTRI/2014/08/004904已完成4 期
A comparative study of the clinical efficacy and safety of agomelatine 25 mg (or 50 mg) with escitalopram 10 mg (or 20 mg) in major depressive disorder patients:a 24 weeks randomized open label parallel group study. - RACE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入选标准
- •i) Age should be between 18-65 years with normal liver function.
- •ii) Patient should be newly diagnosed of Major Depressive Disorder(MDD)-Patient who first time consult psychiatrist for the complaints suggestive of Major Depressive Disorder(MDD).
- •iii) Patient is willing to give written informed consent.
排除标准
- •i) Pregnant and Nursing Women
- •ii)Patientâ??s on other antidepressants.
- •iii)Patient with high risk of suicide or previous suicide attempt within 6 months, bipolar disorder, anxiety symptoms such as panic attacks, obsessive-compulsive disorder, posttraumatic stress disorder, drug abuse or dependency, previous depression resistant to antidepressants, and treatment with electroconvulsive therapy within 3 months or formal psychotherapy within 1 month.
- •iv)Patient with neurologic disorders (dementia, seizures, stroke), obesity with functional impairment, serious or not stabilized organic disorders (neoplasia, cardiovascular, pulmonary, uncontrolled type 1 or 2 diabetes)
- •v)Patient with â??resistant depressionâ?? defined as patients who have not responded to two different previous antidepressant treatment for at least four weeks at an appropriate dose.[9]
- •v)Shift workers, women without effective contraception
研究者
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