Effect on Efficacy, Safety and Quality of Life by Long-Term Treatment of Long-Acting Risperidone Microspheres in Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
研究概览
简要总结
The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, 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) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and safety will be monitored throughout the study.
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
- •Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
- •Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication
- •Participants who have signed informed consent form
排除标准
- •Participants who have never received any previous antipsychotic treatment
- •Participants who have received clozapine during the last 3 months
- •Participants with a serious unstable medical condition, including laboratory abnormalities
- •Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
- •Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception
研究组 & 干预措施
Risperidone Long-Acting Injectable (RLAI)
The RLAI 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 2 years.
干预措施: Risperidone Long-Acting Injectable (RLAI) (Drug)
结局指标
主要结局
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
时间窗: Baseline and Week 96
The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
次要结局
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96(Baseline and Week 96)
- Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96(Baseline and Week 96)
- Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96(Baseline and Week 96)
- Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96(Baseline and Week 96)
- Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96(Baseline and Week 96)
- Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96(Baseline and Week 96)
- Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96(Baseline and Week 96)
- Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96(Baseline and Week 96)
- Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96(Baseline and Week 96)
- Change From Baseline in NCFT: TMT-Error at Week 96(Baseline and Week 96)
- Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score(Baseline and Week 96)
- Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96(Baseline and Week 96)
- Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score(Baseline and Week 96)