A comparative study to assess the effectiveness and cardio-metabolic safety profile of Lurasidone versus Olanzapine in patients with Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Clinical Global Impressions Scale – Impressions and Montreal Cognitive Assessment would be used to assess change in symptoms of Schizophrenia.
研究概览
简要总结
This study is a randomized, single blind, parallel group, single-centre trial comparing the effectiveness and cardio metabolic safety of Lurasidone and olanzapine for 12 months in 120 patients with Schizophrenia that will be conducted in India. The primary outcome measures will be Positive andNegative Syndrome Scale, Brief Psychiatric Rating Scale and ClinicalGlobal Impressions Scale – Impressions at 6 weeks. The secondary outcomes will be LipidProfile, Fasting Blood Sugar, Post Prandial Blood Sugar and ECGat 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients giving informed consent, diagnosed with Schizophrenia as per ICD 10 diagnostic criteria and drug free for atleast 8 weeks.
排除标准
- •Known case of diabetes mellitus, dyslipidemia and cardiac illness.
- •Systemic or neurological Disorder affecting cognition, behavior or mental status.
- •Substance dependence except nicotine and caffeine within the past month of entering the study.Long standing medical or surgical illness and patients with mental retardation or organic brain disease.
结局指标
主要结局
Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Clinical Global Impressions Scale – Impressions and Montreal Cognitive Assessment would be used to assess change in symptoms of Schizophrenia.
时间窗: At the time of enrollment in the study and at the end of 6 weeks.
次要结局
- Lipid Profile, Fasting Blood Sugar, Post Postprandial Blood Sugar and ECG would be done to assess change in cardio metabolic parameters in the patients.(At the time of enrollment in the study and at the end of 6 weeks.)