CTRI/2024/09/073456尚未招募不适用
A Comparative study to evaluate the efficacy and safety of Olanzapine and Cariprazine in patients with Bipolar disorder
Dr Mukesh kumar1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年9月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
To campare the efficacy and safety of Olanzapine 5mg once a day and Cariprazine 1.5mg once a day in patients of Biploar Disorder .These study is the Prospective Randomized Double Blind Parallel group drug study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients or attendant giving written informed consent 2 Male and female patients who met diagnostic criteria for bipolar disorder and a major depressive episode as defined by DSM-IV 3 Patients will be required to have been in a depressive episode.
排除标准
- •1 Patient not willing to participate in the study.
- •2 Unstable medical illness 3 History of diabetes 4 Recent substance dependence.
- •5 History of serious psychiatric illness other than bipolar disorder.
- •â€¢depot antipsychotics or central nervous system medications other than mood stabilisers •Current rapid-cycling mood disturbance.
结局指标
主要结局
Quality of life
时间窗: Baseline, 2weeks, 4weeks,
次要结局
- Adverse drug reaction of drugs(Every 2 weeks for 4 weeks.)
研究者
Dr Anil kumar
Baba Raghav Das Medical college.Gorakhpur
研究点 (1)
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