Clinical Observation of the Efficacy and Safety of Risperidone Long-Acting Injection (Risperdal Consta) in the Treatment of Schizophrenia in China
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 640
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the long-term treatment efficacy, and safety of risperidone long-acting injection in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center), prospective (study following participants forward in time) and observational study of risperidone long-acting injection in participants with schizophrenia. The study consists of 2 parts: Screening (that is, 28 days before study commences on Day 1) and Treatment (that is, Week 1-24). All the eligible participants (after risperidone intolerance test during screening) will be receiving risperidone as intramuscular injection (injection of a substance into a muscle) at a dose of, either 25 milligram (mg), 37.5 mg or 50 mg every two weeks. Efficacy of the participants will be primarily evaluated through Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout 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
- •Male or female, age 18-65 years
- •Participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)-TM
- •Total course of disease no more than 5 years
- •According to physician's discretion, participants need to be changed to risperidone long-acting injection and other atypical anti-psychotic drug
- •Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •Significant risk of suicidal or violent behavior, as clinically assessed by the Investigator
- •Have aggressive behavior and excited , restless
- •History or current symptoms of tardive dyskinesia; neuroleptic malignant syndrome; evidence of dysfunction of liver and kidney and other severe physical diseases; and severe, life-threatening allergic reaction to any drug
- •Known hypersensitivity to risperidone
- •Female participant who is pregnant or breastfeeding or planning to become pregnant during the study period
研究组 & 干预措施
Risperidone
Risperidone will be administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose will be decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may be increased or decreased at physician discretion. For first three weeks, previous oral antipsychotic drug (Benzodiazepines or Selective serotonin reuptake inhibitor [SSRI]) will be maintained and will cease at Week 3.
干预措施: Risperidone (Drug)
Oral atypical anti-psychotic
Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc will be administered as per Investigator's discretion.
干预措施: Oral atypical anti-psychotic (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
时间窗: Baseline and Week 24
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
次要结局
- Number of Participants With Reasons for Discontinuation From Study Treatment(Month 6)
- Total Personal and Social Performance (PSP) Score(Baseline and Week 24)
- Clinical Global Impressions-Severity (CGI-S) Score(Baseline and Week 24)
- Percentage of Participants With Relapse at Week 24(Week 24)
- Percentage of Participants Attaining Remission Criteria(Month 6)