A Single-arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 主要终点
- The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
详细描述
Patients with schizophrenia or schizoaffective disorder commonly have other conditions that may affect the liver, such as alcohol abuse and/or chronic liver infections (hepatitis). Although single-dose studies in patients with liver disease are conducted to test the safety of medications, there is less information about the safety of treatment with medications for schizophrenia in this at-risk population of patients with schizophrenia or schizoaffective disorder and liver disease. This 9-week study is open-label (both patient and investigators know what study drug and dose of study drug the patient is taking) and has 2 phases. During Phase 1, which lasts 4 weeks, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual). During the first week of Phase 2, patients will receive decreasing doses of TAU and increasing doses of paliperidone ER. For the rest of Phase 2, which lasts 4 more weeks, patients will take paliperidone ER in doses between 3 mg/day and 12 mg/day, as prescribed by the study doctor. This study will evaluate adverse events and will use several scales and tests to measure the effectiveness of paliperidone ER in patients with an established diagnosis of schizophrenia or schizoaffective disorder and liver disease. Study assessments include the PANSS (Positive and Negative Symptom Scale for Schizophrenia), CGI (Clinical Global Impression scale), MSQ (Medication Satisfaction Questionnaire), sleep VAS (Visual Analog Scale), SF-36 (Short Form 36 Health Survey), and PSP (Personal and Social Performance Scale). Each assessment will be performed at least two times during the course of the study, but some assessments will be done more frequently. Visits are scheduled every 1 to two weeks during the 9 week study.
The hypothesis is that paliperidone ER can be used safely in patients with schizophrenia or schizoaffective disorder who also have identified liver disease. During Phase 1 of the study, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual) for 4 weeks. For the first week of Phase 2, patients will receive decreasing doses of TAU. During Phase 2, patients will take paliperidone ER in doses between 3 milligrams per day and 12 milligrams per day by mouth for 5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening
- •Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
- •Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic cirrhosis)
- •Child-Pugh class A or B (total score < 10)
排除标准
- •Not able to swallow the study medication whole with the aid of water
- •Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV diagnosis of Bipolar Disorder
- •Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance abuse or dependence or alcohol abuse or dependence in the 6 months before study entry
- •Not experiencing severe liver disease or an acute exacerbation of the underlying liver disease (Child-Pugh total score >=10)
- •No evidence of severe hepatic decompensation within the previous 3 months, such as: ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)
研究组 & 干预措施
001
Treatment as usual (TAU), Paliperidone ERTreatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
干预措施: Treatment as usual (TAU), Paliperidone ER (Drug)
结局指标
主要结局
The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
时间窗: Day 1 - Day 62
Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.
次要结局
- Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline(Day 1 - Day 62)
- Clinical Global Impression of Severity (CGI-S) Change From Baseline(Day 1 - Day 62)
- Personal and Social Performance Score (PSP) Change From Baseline(Day 1 - Day 62)