Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Functional remission dimension 2
研究概览
简要总结
Study objectives:
- Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation.
- Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.
详细描述
There are 2 clinically important and urgent questions to be explored in this study: 1. Who is more likely to benefit from guided drug reduction or discontinuation? How to design an individualized treatment plan which can balance the risk of relapse and side-effects from antipsychotics? 2. What are the predictors of functional remission in patients with schizophrenia after drug discontinuation? This will be the first related study to be conducted in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients who met the diagnostic criteria of the International Classification of diseases, 10th edition (ICD-10) for a diagnosis of schizophrenia;
- •Aged between 18 to 65 years old at time of investigation;
- •Hospitalized in Shanghai Mental Health Center any time from the year 2013 to 2018;
- •Informed consent.
排除标准
- •Patients with neurological diseases, severe somatic diseases, psychoactive substance abuse, mental retardation, agitation, stupor, or risk of suicide, and female patients who are pregnant or breast-feeding, will be excluded from the study.
结局指标
主要结局
Functional remission dimension 2
时间窗: Up to 28 weeks
Functional Remission of General Schizophrenia Scale (FROGS), scale from 19 to 95. Higher score indicates better functional remission.
Functional remission dimension 1
时间窗: Up to 28 weeks
World Health Organization Quality of Life abbreviated version（WHOQoL-BREF), score from 26 to 130. Higher score indicates better functional remission.
次要结局
- Symptom assessment dimension 2(Up to 28 weeks)
- Symptom assessment dimension 1(Up to 28 weeks)