Evaluation of Efficacy and Safety of Paliperidone Among People With Schizophrenia in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- Change in PANSS total score from baseline to 12 weeks
研究概览
简要总结
This is a single-arm, open-label, multicenter, prospective quasi-experimental study evaluating the efficacy and safety of extended-release paliperidone in adults with schizophrenia in Bangladesh. The study will assess psychotic symptom improvement using the PANSS scale, monitor side effects using GASS, and evaluate quality of life via WHOQOL-BREF.
详细描述
Despite global evidence supporting the effectiveness of paliperidone, there is limited data from low- and middle-income countries such as Bangladesh. This study addresses this evidence gap by assessing the efficacy and safety of paliperidone ER in a real-world, multi-site setting. The primary endpoint is the change in PANSS score after 12 weeks of treatment. Secondary outcomes include side-effect profile, safety assessments, and quality of life. A total of 505 participants will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years
- •Diagnosed with schizophrenia according to DSM-5 criteria
- •At least 3 months since the initial diagnosis of schizophrenia
- •Either antipsychotic-naïve or previously treated with one antipsychotic but requiring a change due to non-response, poor response, or intolerable side effects. (If previously treated, a washout period of 7 days before study medication initiation)
- •PANSS (Positive and Negative Syndrome Scale) total score ≥70
- •Clinically stable for at least 2 weeks before enrollment
排除标准
- •History of being diagnosed with treatment-resistant schizophrenia
- •Comorbid severe medical or neurological conditions
- •Pregnant or lactating women
- •Previous known hypersensitivity to paliperidone or risperidone
- •Use of long-acting injectable antipsychotics within the last 3 months
- •Current diagnosis of substance related disorder or substance misuse in the previous month
研究组 & 干预措施
Paliperidone Extended-Release Treatment Arm
Participants in this arm will receive paliperidone extended-release (ER) tablets at a flexible daily dose of 6-12 mg, as determined by the treating psychiatrist based on clinical judgment. The treatment will continue for 12 weeks, with clinical assessments at baseline, 6 weeks, and 12 weeks to evaluate efficacy, safety, and quality of life.
干预措施: Paliperidone extended-release (ER) (Drug)
结局指标
主要结局
Change in PANSS total score from baseline to 12 weeks
时间窗: Baseline, Week 6, Week 12
The Positive and Negative Syndrome Scale (PANSS) will be used to assess the severity of schizophrenia symptoms. The total score ranges from 30 to 210, with higher scores indicating more severe symptoms. The primary outcome is the change in total PANSS score from baseline to week 12 following treatment with paliperidone extended-release.
次要结局
- Assessment of Side Effects Using GASS Score(Baseline, Week 6, and Week 12)
- Changes in Quality of Life Measured by WHOQOL-BREF(Baseline and Week 12)
研究者
Mohammad Tariqul Alam
Professor
Sher-E-Bangla Medical College