Prospective, Observational study on Efficacy and Safety of Dextromethorphan-Bupropion in Comparison to Desvenlafaxine in Patients with Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
研究概览
简要总结
This is prospective observational study and aim of the study is to compare safety and efficacy of two pharmacological treatments Dextromethorphan-Bupropion and Desvenlafaxine in reducing depressive symptoms in patients with MDD. A total of 128 patients who meets the inclusion criteria and who will provide written informed consent will be recruited for the study. The diagnosis and the drug to be prescribed will be decided by the consultant psychiatrist. Patients who will be prescribed drug Desvenlafaxine & drug Dextromethorphan-Bupropion will be taken for study. Both groups will be observed for 12 weeks and follow up will be taken on 2nd, 4th ,6th and 12th week. The symptoms of depression will be assessed on every follow up to know the efficacy of drug using clinical rating scales Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression- Improvement Scale CGI-I and safety of drugs will be assessed using Frequency, Intensity and burden of Side effects Rating (FIBSER), Arizona Sexual Experience Scale (ASEX), Antidepressant Side Effect Checklist (ASEC).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with age of 18 to 60 years.
- •2 Patients with first episode of Major Depressive Disorder 3 Scores of MADRS more than
- •4 Patients with MDD who will be prescribed Desvenlafaxine or Dextromethorphan-Bupropion.
- •5 The participants who will provide written informed consent.
排除标准
- •Non-consent for participation in the study 2.Age less than 18 years and more than 60 year.
- •Primary diagnosis of any ANXIETY DISORDER (GAD), SOCIAL ANXIETY DISORDER, PANIC DISORDER, PTSD, SUBSTANCE USE DISORDER, BIPOLAR DISORDER, current or past comorbid diagnosis of SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDER, DELUSIONAL DISORDER, PSYCHOTIC DISORDER not otherwise specified, ORGANIC MENTAL DISORDER including DEMENTIA, EATING DISORDER, OCD, SEIZURE DISORDER, comorbid serious comorbid condition hypo or hyperthyroidism.
- •4.Patients with Risk for suicide 5.Patients who are not on drug Dextromethorphan- Bupropion or drug Desvenlafaxine.
- •Patient with clinically significant condition, pulmonary, central nervous system (stroke, dementia), uncontrolled hypertension and Diabetes at screening, renal disease 7.Patients with cardiac condition in the last six months (including but not limited to the, myocardial infarction, moderate to severe congestive heart failure, congenital prolongation of QT, symptomatic bradycardia, Bazett’s corrected QT (more than 460msec if male or more than 470msec if female)
- •Pregnant or lactating women.
研究者
Dr Thakur Sakshi Maliksingh
Dr. M.K Shah medical college and research centre