A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
详细描述
This study plans to enroll 120 patients diagnosed with schizophrenia per DSM-5 criteria who have achieved clinical stability on oral antipsychotic therapy. Patients will receive monotherapy with Paliperidone Palmitate Injection. Assessments will be conducted at baseline, Day 35±7, Day 91±7, and Day 175±7. Adverse events and concomitant medications will be recorded during follow-up visits.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia;
- •Aged 18-65 years (inclusive), regardless of gender;
- •Currently receiving first- or second-generation oral antipsychotics (excluding clozapine) with stable condition as assessed by the investigator, and PANSS total score ≤80 at screening and baseline;
- •Signed informed consent by the patient and/or guardian;
排除标准
- •Comorbid psychiatric diagnoses other than schizophrenia;
- •Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses;
- •QTc interval >450 ms (male) or >460 ms (female);
- •History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies;
- •Current or history of tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal symptoms (EPS);
- •Treatment-resistant schizophrenia (failure of ≥2 adequate antipsychotic regimens of different compounds);
- •Hypersensitivity or inefficacy to risperidone or paliperidone;
- •Pregnancy, lactation, planned pregnancy, or failure to use effective contraception during the study;
- •9. Other conditions deemed unsuitable by the investigator. |
研究组 & 干预措施
Treatment group
Switching from Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia Patients
干预措施: Paliperidone Palmitate Injection (PP1M) (Drug)
结局指标
主要结局
The Positive and Negative Syndrome Scale (PANSS)
时间窗: Day 175±7
The Positive and Negative Syndrome Scale (PANSS) is a standardized clinical assessment tool used to evaluate the severity of symptoms in patients with schizophrenia. It measures three domains: Positive Symptoms (e.g., hallucinations, delusions), Negative Symptoms (e.g., social withdrawal, blunted affect), General Psychopathology (e.g., anxiety, guilt). Scores are derived from a 30-item structured interview, with each item rated on a 7-point scale (1=absent to 7=extreme). Higher total scores indicate more severe symptomatology. Widely used in research and clinical settings, PANSS helps monitor treatment efficacy and disease progression.
次要结局
- Extrapyramidal Symptom Rating Scale (SAS)(Baseline, Day 35±7, Day 91±7, Day 175±7)
- Personal and Social Performance (PSP)(Baseline, Day 35±7, Day 91±7, Day 175±7)
- EuroQol-5 Dimensions (EQ-5D)(Baseline, Day 35±7, Day 91±7, Day 175±7)
- Clinical Global Impression-Severity (CGI-S)(Baseline, Day 35±7, Day 91±7, Day 175±7)
- Abnormal Involuntary Movement Scale (AIMS)(Baseline, Day 35±7, Day 91±7, Day 175±7)
- Barnes Akathisia Rating Scale (BARS)(Baseline, Day 35±7, Day 91±7, Day 175±7)