Study of Efficacy and Safety of Cariprazine Augmentation in Major Depressive Disorder
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The severity of Depressive disorder which will be measured by percentage MADRS, HAMD score change from baseline and at the end of 6 weeks.
研究概览
简要总结
This study aims to study the efficacy , safety and tolerability of Cariprazine as an adjunctive treatment in Major Depressive Disorder. Secondary objectives include comparing effects as well as adverse drug reactions of Cariprazine with different antidepressants. Conducted over 6 months at Jawaharlal Nehru Medical College, AMU, Aligarh, UP, this prospective, parallel arm , cross sectional study will include adult patients diagnosed with Major Depressive Disorder as per DSM-5 criteria. Participants will undergo comprehensive clinical history assessments and baseline evaluation using MADRS, HAMD scales. Sixty patients will be randomised into two groups : Group A will receive Cariprazine 1.5 mg and Group B will receive Cariprazine 3.0mg. Evaluation will be done at the end of 2, 4 and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •DSM 5 criteria for Major depressive disorder.
- •Able to give consent.
- •MADRS score more than 20 despite adequate trial of one antidepressant.
- •patients on stable dose of same antidepressant for past 2 weeks.
排除标准
- •Patients who have bipolar depression, depression with psychotic features.
- •Any other comorbid psychiatric or medical diagnosis.
- •Not able to give consent.
- •Taking any other medications except benzodiazepine.
结局指标
主要结局
The severity of Depressive disorder which will be measured by percentage MADRS, HAMD score change from baseline and at the end of 6 weeks.
时间窗: 6 months
次要结局
- Response or remission rate will be calculated at each time point (2, 4 and 6 weeks) using MADRS and HAMD score.(6 months)
研究者
Dr Shreya Agrawal
Jawaharlal Nehru Medical College, Aligarh Muslim University