A Precision Medication Guidance Model for Schizophrenia Based on Pharmacogenomics and Physiologically Based Pharmacokinetics: a Real-World Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8
研究概览
简要总结
An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.
详细描述
This study, conducted at the Shanghai Mental Health Center, aims to compare changes in treatment efficacy and the frequency and severity of adverse reactions in patients with schizophrenia who have experienced treatment failure, before and after implementing a pharmacogenomics-based precision medication guidance strategy. The research is set in real-world conditions, without a predetermined treatment regimen for participants; instead, medication optimization is guided by pharmacogenomic testing results. Following the receipt of precision medication recommendations for each participant, the study physicians optimize the treatment regimen based on these recommendations and their clinical expertise. Optimization may involve adjusting the dose of current medications (if the existing regimen is largely suitable), switching medications (in cases of inappropriate treatment), or modifying the dose or replacing one of the combined medications (to manage drug-drug interactions). The rationality of the medication regimen will be assessed at the end of weeks 4 and 8, with additional recommendations provided as needed. Treatment effectiveness and safety will be evaluated during follow-up visits at these intervals. A total of 400 patients are planned to be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
- •Age between ≥18 and <65 years.
- •Currently receiving inpatient or outpatient psychiatric treatment.
- •Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:
- •Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
- •Antipsychotic treatment within the therapeutic dosage range for more than 4 weeks, with the presence of at least two items of the Positive and Negative Syndrome Scale (PANSS) (P1, P2, P3, N1, N4, N6, G5, and G9) score ≥4, or a total PANSS score >70, or a CGI-S score ≥
- •Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.
- •Understand the study requirements and provide written informed consent to participate; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.
排除标准
- •Presence of organic brain disease or a severe and/or unstable physical condition.
- •Substance abuse or dependence within the past 6 months or currently.
- •Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
- •Pregnant or breastfeeding women.
- •The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8
时间窗: 4 weeks and 8 weeks
The Positive and Negative Syndrome Scale (PANSS) provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. Score range 30-210. A higher score means a worse outcome.
次要结局
- Change in the Calgary Depression Scale for Schizophrenia (CDSS)(4 weeks and 8 weeks)
- Change in the Clinical Global Impression of Severity (CGI-S)(4 weeks and 8 weeks)
- Clinical Laboratory Tests(4 weeks and 8 weeks)
- Safety Assessment by the Treatment Emergent Symptom Scale (TESS) score(4 weeks and 8 weeks)
- Safety Assessment by Barnes Akathisia Rating Scale(BARS)(4 weeks and 8 weeks)
- Safety Assessment by Simpson-Angus Scale(SAS)(4 weeks and 8 weeks)
- Safety Assessment by Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score(4 weeks and 8 weeks)