An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,117
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
研究概览
简要总结
The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.
详细描述
This is a single arm (one group of participants), multi-center, 6-month study to explore the tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with schizophrenia previously unsuccessfully treated with an oral antipsychotic medication. Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the participant was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout the study the investigators will adjust the dosage of each participant based on the individual needs. In general, the recommended paliperidone ER dose will be 6 milligram once daily. Participants can be either in- or outpatients and they may take their study drug with or without food. Participants who will complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available.
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
- •Participant diagnosed with schizophrenia
- •Participant's previous treatment of schizophrenia is considered unsuccessful
- •Participant is healthy on the basis of a physical examination and vital signs
- •Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
- •Be willing and able to fill out self-administered questionnaires
排除标准
- •Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
- •Judged to be at high risk for adverse events, violence or self-harm
- •Inability to swallow the study medication whole with the aid of water
- •Pregnant or breast-feeding female
- •History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
研究组 & 干预措施
Paliperidone ER: Lack of efficacy
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
干预措施: Paliperidone ER (Drug)
Paliperidone ER: Lack of tolerability, compliance or other
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
干预措施: Paliperidone ER (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
时间窗: Baseline and Week 26
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
次要结局
- Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26(Week 26)
- Change From Baseline in PANSS Total Positive Subscale Score at Week 26(Baseline and Week 26)
- Change From Baseline in PANSS Total Negative Subscale Score at Week 26(Baseline and Week 26)
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26(Baseline and Week 26)
- Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26(Baseline and Week 26)
- Change From Baseline in Sleep Quality at Week 26(Baseline and Week 26)
- Change From Baseline in Daytime Drowsiness at Week 26(Baseline and Week 26)
- Number of Participants Within Each Category of Patient Satisfaction Score(Baseline and Week 26)