A study to evaluate the clinical effectiveness of multigenetic pharmacogenomics guided treatment in drug naive schizophrenics in northern Indian population an open label randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The time course of schizophrenia severity which will be measured by the percentage PANSS score change from baseline and at the end of 3 month
研究概览
简要总结
This study aims to compare the clinical effectiveness of multi-genetic pharmacogenomics-guided treatment versus standard treatment in drug-naive schizophrenic patients. Secondary objectives include comparing adverse drug reaction profiles and conducting a cost-benefit analysis. Conducted over 18 months at Jawaharlal Nehru Medical College, AMU, Aligarh, UP, this prospective, parallel-arm, open-label, randomized control trial will involve adult patients diagnosed based on ICD 11 criteria. Participants will undergo comprehensive clinical history assessments and baseline evaluations using the PANSS and CGI scales. Sixty patients will be randomly divided into two groups: Group A will receive standard treatment, and Group B will receive pharmacogenomics-guided treatment. Evaluations will be conducted at the end of the 1st, 2nd, and 3rd months.
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
- •1.ICD-10 or 11 criteria for schizophrenia 2.Positive and Negative Syndrome Scale (PANSS) more than 60 score 3.Patient or legally authorized representative willing to give informed consent 4.Two generations of the patient living in northern India 5.Schizophrenic patients who have not received any psychotropics.
排除标准
- •1.Concurrent substance use disorders 2.Neurological conditions 3.Other comorbid axis I psychiatric diagnoses 4.Severe unstable organic illnesses 5.Not able to give consent 6.Pregnant or lactating females.
结局指标
主要结局
The time course of schizophrenia severity which will be measured by the percentage PANSS score change from baseline and at the end of 3 month
时间窗: 18 months
次要结局
- Response or remission rate will be calculated at each time point (1, 2, 3 months) using the PANSS score(Early remission: change of 20 % in PANSS score)
研究者
Dr Amrita Kumari Pandey
Jawaharlal Nehru Medical College and Hospital