A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services
研究概览
简要总结
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.
详细描述
The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
- •Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
- •Have a current diagnosis of schizophrenia
- •Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
- •Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control
排除标准
- •Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
- •Actively abusing intravenous drugs
- •Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- •have an unstable medical illness
- •Women who are pregnant or breast-feeding, or planning to become pregnant
- •Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
- •Received treatment with clozapine within 3 months of screening
- •Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening
- •homeless at time of stuyd consent
研究组 & 干预措施
001
paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months
干预措施: paliperidone palmitate (Drug)
002
olanzapine flexible dosing as prescribed by the study doctor for 12 months
干预措施: olanzapine (Drug)
003
paliperidone flexible dosing as prescribed by the study doctor for 12 months
干预措施: paliperidone (Drug)
004
aripiprazole flexible dosing as prescribed by the study doctor for 12 months
干预措施: aripiprazole (Drug)
005
haloperidole flexible dosing as prescribed by the study doctor for 12 months
干预措施: haloperidole (Drug)
006
perphenazine flexible dosing as prescribed by the study doctor for 12 months
干预措施: perphenazine (Drug)
007
quetiapine flexible dosing as prescribed by the study doctor for 12 months
干预措施: quetiapine (Drug)
008
risperidone flexible dosing as prescribed by the study doctor for 12 months
干预措施: risperidone (Drug)
结局指标
主要结局
Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services
时间窗: Up to 12 months
次要结局
- Change in Clinical Global Impression-Severity score(Up to 12 months)
- Change in Global Assessment of Functionality score(Up to 12 months)
- Change in Medication Satisfaction Questionnaire score(Up to 12 months)
- Proportion of subjects with at least one psychiatric hospitalization(Up to 12 months)