Efficacy of Bupropion-Dextromethorphan fixed dose combination versus Sertraline in major depressive disorder patients: a non-inferiority randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proportion of participants responding based on a predefined change in MADRS score at 6 weeks of therapy.
研究概览
简要总结
Approval from Institute Ethics Committee will be obtained before commencement of this study. Study protocol will be registered in clinical trial registry of India. Informed consent will be obtained from all the volunteers, followed by screening for eligibility. Participants will be required to attend six visits over a 6 week trial period followed by one week safety assessment. Procedures for the ingestion of study drugs will be consistent between the trial groups. Participants will be called for follow-up at weeks 1, 2, 4, 6 and 7. Improvement in scores will be assessed through various scales at follow-up visits. Study will be conducted following principles of Declaration of Helsinki and good clinical practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Falling into age range of 18-65 years.
- •Confirmed MDD (DSM-5 criteria) patient experiencing a major depressive episode for at least 4 weeks.
- •Baseline MADRS score of 20 or higher, corresponding to moderate or greater severity and CGI-S of 4 or higher.
- •Ability to provide informed consent.
排除标准
- •Patients with treatment resistant depression (at least two failed treatments in the current depressive episode).
- •Patients receiving treatment for Psychotic Disorder, Bipolar Disorder, Panic Disorder, Obsessive compulsive Disorder or Seizure Disorder.
- •Current Alcohol or substance use or dependence within the past 12 months.
- •Any patient with high risk of suicide.
- •Pregnant woman or Breastfeeding mother.
- •Allergy to any of the components of study drug(s).
结局指标
主要结局
Proportion of participants responding based on a predefined change in MADRS score at 6 weeks of therapy.
时间窗: 6 weeks
次要结局
- Secondary outcomes(Change in MADRS score at 6 weeks of therapy)
研究者
Dr Vikas Maharshi
AIIMS, Patna