CTRI/2017/10/010060已完成3 期
A Double-blind, Randomized, Multicentric, Active Controlled, Parallel Group, Comparative Phase III Study to evaluate the Efficacy and Safety of Levomilnacipran ER versus Venlafaxine hydrochloride XR in patients with major depressive disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
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
- •1. Newly diagnosed patients with Major Depressive Disorder (MDD)
- •2. Outpatients (18-65 years) meeting DSM-IV criteria for a major depressive episode (duration ââ?°Â¥ 1 month)
- •3. MDD patients with a 17-item Hamilton Depression Rating Scale (HDRS17) score > 22 and Sheehan Disability Scale (SDS) score ââ?°Â¥ 10
- •4. Women of child bearing age willing to take contraceptive measure to prevent pregnancy during the study
- •5. Patients willing to give written informed consent
排除标准
- •1. History of hypersensitivity to the study drugs
- •2. Patients with suicidal ideation where study participation is deemed unsafe by the study clinician
- •3. Women who are pregnant or breastfeeding, or women of childbearing potential not using a medically accepted means of contraception
- •4. Serious or unstable medical illness such as liver disease, renal disease or Cardiovascular disease
- •5. Patient with history of narrow angle Glaucoma
- •6. Lifetime history of organic mental disorder, schizophrenia spectrum illness, bipolar disorder that would interfere with trial assessments
- •7. MDD with psychotic features, substance use disorder such as alcohol or nicotine active in the prior 12 months
- •8. Significant bleeding disorder
- •9. Patients with any alcohol or substance dependence in the past 6 months, major physical illness, significant ECG, hepatic or renal liver abnormalities
- •10. Patient having cardiac abnormalities as confirmed by ECG.
- •11. Current use of other psychotropic drugs other than antihistamines
- •12. History of drug abuse or alcohol abuse
- •13. Patients with investigational psychotropic drug use in the prior 3 months
- •14. Presence of any significant disease including immunodeficiency, hepatic, renal, cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.
- •15. Clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders. Clinically relevant or unstable cardiovascular diseases .Type 1 or poorly controlled type 2 diabetes mellitus (hemoglobinA1c: ââ?°Â¥9%). Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy.
- •16. Patients taking concomitant medications with primarily central nervous system activity
- •17. Patients participating in any other clinical trial in the past 3 months.
- •18. Patients with obsessive compulsive disorder, with manic or hypomanic episode, schizophrenia or any other psychotic disorder.
研究者
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