An Open-Label Randomized Trial Comparing Risperdal Consta With Oral Antipsychotic Care in the Treatment of Early Psychosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).
详细描述
This is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality) or schizoaffective disorder (mixed psychiatric disorder relating to complex psychotic state that has features of both schizophrenia and mood disorder). Duration of this study will be 24 months. Study assessment visits will be conducted at Screening, Baseline, Week 2, every 4 weeks till Week 22, at Week 28, every 12 weeks till Week 88 and at Week 104. All eligible participants will receive either risperidone long acting injection 25 milligram (mg) intramuscularly (into the muscle) along with their current oral medication (atypical antipsychotic - risperidone, quetiapine, olanzapine) or only their current oral medication. Efficacy will be evaluated primarily by Positive and Negative Syndromes Scale (PANSS), time to relapse and Social and Occupational Functioning Assessment Scale (SOFAS). Participants's safety will be evaluated throughout the study mainly by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS).
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patients or out-patients
- •Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness
- •Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2
- •Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive
- •Able to complete self-assessments in either English or French
排除标准
- •Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to DSM-IV
- •Current drug or alcohol dependence
- •Treatment with a depot antipsychotic within 3 months of study start
- •Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone
- •Risperidone non-responders (based on evidence of adequate trial of treatment)
研究组 & 干预措施
Risperidone long-acting injection (LAI)
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
干预措施: Risperidone long-acting injection (LAI) (Drug)
Oral Antipsychotic
Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants will be switched to another oral therapy as per Investigator's discretion.
干预措施: Oral Antipsychotic (Drug)
结局指标
主要结局
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV
时间窗: Baseline, Week 104 or LRV
The SOFAS focused exclusively on participants' level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)
时间窗: Baseline, Week 104 or LRV
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each 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 to 210. Higher scores indicate worsening.
Time to Relapse
时间窗: Week 10 (post-stability) up to Week 104 or LRV
Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: "Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)".
次要结局
- Percentage of Participants With Relapse(Week 10 (post-stability) up to Week 104 or LRV)
- Number of Participants With Cognitive Assessment Using Trail A(Week -2, 104 or LRV)
- Number of Participants With Cognitive Assessments Using Trail B(Week -2, 104 or LRV)
- Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV(Baseline, Week 104 or LRV)
- Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV(Baseline, Week 104 or LRV)
- Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV(Baseline, Week 104 or LRV)
- Total Words Score Over Time(Baseline, Week 104 or LRV)
- Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV(Up to Week 104 or LRV)
- Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV(Up to Week 104 or LRV)