Comparative Efficacy and Safety of Olanzapine and Cariprazine in Patients of Acute Psychosis in a Tertiary Care Hospital Of Western Uttar Pradesh.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To assess the efficacy and safety of Olanzapine and Cariprazine in the treatment of acute psychosis.
研究概览
简要总结
Inclusion of Eligible Patients: Patients fulfilling the inclusion/exclusion criteria will be enrolled after obtaining written informed consent using the Institutional Ethics Committee–approved Informed Consent Form (ICF). Demographic details such as age, gender, education, contact number, and address will be recorded. c) Group Allocation: Patients will be randomized via computer-generated codes into: Group 1: Olanzapine (5–20 mg/day) Group 2: Cariprazine (1.5–6 mg/day) d) Baseline Assessments: Prior to treatment initiation, the following scales and measurements will be recorded: Brief Psychiatric Rating Scale (BPRS), Simpson Angus Scale (SAS), Barnes Akathisia Scale, AIMS (Abnormal Involuntary Movement Scale) and Weight, Blood Pressure, Blood Glucose, Lipid Profile
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with acute psychosis.
- •2.Willingness to participate and provide informed consent 3.Treatment naive patient or patients not taking any antipsychotic medication for last one month.
排除标准
- •1.Pregnant and lactating women.; 2.Severe Medical Illnesses and co morbid conditions 3.Any known Contra-indications to the use of Olanzapine and Cariprazine example known allergy or hypersensitivity 4.Treatment-resistant psychosis.
- •5.History of substance abuse or dependence.
结局指标
主要结局
To assess the efficacy and safety of Olanzapine and Cariprazine in the treatment of acute psychosis.
时间窗: From baseline to End of Treatment at 90 days
次要结局
- To evaluate the quality of life using Quality Adjusted Life Years Questionnaire(in patients of acute psychosis)
研究者
Dr Ekta Arora
Government Institute of Medical Sciences (GIMS)