A Randomized, Open-label, Active-controlled Study to Evaluate Social Functioning of Long Acting Injectable Risperidone and Oral Risperidone in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).
详细描述
This is a randomized (treatment group assigned by chance), open-label (all involved people know the identity of the study drug), active-controlled study to evaluate the improvement in social functioning among participants with schizophrenia taking LAI risperidone and oral risperidone tablet. The study drug will be administered for 52 weeks in flexible dose (range as per Investigator's discretion) and a total of 11 assessment visits will be conducted per participant, including Screening. The participant may be withdrawn from the trial for any medical reason at the sole discretion of the investigator. Before starting the study treatment, participants undergo the period of switching from the previous medication to risperidone for 4 weeks, and then they will be evaluated for tolerability for 2 weeks (run-in period for stabilizing to risperidone). In this 2-week period, participants will take oral risperidone. The efficacy will be primarily evaluated through Personal and Social Performance Scale. Safety will be evaluated through Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, and Simpson-Angus Rating Scale. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who will understand the objectives and necessary procedures of the study and have signed the informed consent form which specified that they were willing to participate in the study - Participants with schizophrenia or schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with pre-morbid global assessment of functioning score of 71 or higher at Screening - Participants who do not present clinically significant abnormality in biochemistry and electrocardiography - Participants who will be compliant with the study requirements (that is, filling in the questionnaire by themselves) and who are capable of actually performing and willing to implementing them
排除标准
- •Participants who had taken clozapine for the past three months - Participants with mental retardation (Intelligence Quotient less than 70 at the screening) - Participants with history of or currently with a serious disease (cardiovascular, respiratory, neurological [including seizures or significant cerebrovascular], renal, hepatic, hematologic, endocrine, immunologic or other systemic disease) including clinically relevant abnormal level - Participants who have an allergic or hypersensitive reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating female participants
研究组 & 干预措施
Risperidone tablets
干预措施: Risperidone tablets (Drug)
Risperidone long acting injectables
干预措施: Risperidone long acting injectables (Drug)
结局指标
主要结局
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52
时间窗: Baseline and Week 52
The PSP assesses degree of participant's dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
次要结局
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52(Baseline and Week 52)
- Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Social Functioning Scale (SFS) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52(Baseline and Week 52)
- Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52(Baseline and Week 52)
- Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52(Baseline and Week 52)
- Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52(Baseline and Week 52)
- Change From Baseline in Number of Outpatient Clinic Visits at Week 52(Baseline and Week 52)
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52(Baseline and Week 52)
- Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52(Baseline and Week 52)
- Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52(Baseline and Week 52)
- Change From Baseline in Total Outpatients and Inpatients Hours at Week 52(Baseline and Week 52)
- Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52(Baseline and Week 52)