Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Schizoaffective Disorders, Who is Receiving Psychiatric Home-care Treatment, When Switching From Typical Depot or Oral Antipsychotics to Long-acting Risperidone Microspheres
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change From Baseline in Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) and schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), who are receiving psychiatric home-care treatment .
详细描述
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-randomized and single-arm study of long- acting risperidone microspheres in participants with schizophrenia and schizoaffective disorders. The duration of this study will be 6 months and will include following parts: Screening (that is, 28 days before study commences on Day 1), run-in period (that is, Week 1 to 3) and Treatment period (that is, Week 1 to 24). Participants will receive previous medication for the first three weeks during run-in period and previous medications will be tapered off during the third week. Participants will receive long-acting risperidone microspheres starting at a dose of 25 milligram (mg) every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy of the participants will be primarily evaluated through Positive and Negative Syndrome Scale.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- •Participant has been given an adequate dose of an appropriate antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsatisfactory due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- •Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine betahuman chorionic gonadotropin (HCG) pregnancy test at screening; and a negative urine pregnancy test on screening visit
- •Participants or their legally acceptable representatives must have signed an informed consent document
排除标准
- •Participants with a primary, active DSM-IV diagnosis other than schizophrenia and schizoaffective disorder
- •Participants with relevant history or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic or other systemic disease
- •Participants that are previously on concomitant use of Risperdal CONSTA
- •History or current symptoms of tardive dyskinesia
- •History of neuroleptic malignant syndrome (NMS)
研究组 & 干预措施
Risperidone
Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.
干预措施: Risperidone (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndromes 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
- Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Week 24(Baseline and Week 24)
- Short Form-36 (SF-36) - Quality of Life Score(Screening (28 days before study drug administration), Baseline and Week 24)
- Change From Baseline in Simpson Angus Rating Scale (SAS) Score at Week 24(Baseline and Week 24)
- Personal and Social Performance (PSP) Scale Score(Screening (28 days before study drug administration), Baseline and Week 24)
- Number of Participants Compliant With Study Treatment(6 months before administration of study drug and 6 months after administration of study drug)
- Clinical Global Impression (CGI) Scale Score(Screening (28 days before study drug administration), Baseline and Week 24)