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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 主要终点
- Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
研究概览
简要总结
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.
详细描述
This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient meets the criteria for schizophrenia
- •Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- •Patient is healthy on the basis of a physical examination and vital signs at screening
- •Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
排除标准
- •Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
- •Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- •Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
- •Patients judged to be at high risk for adverse events, violence, or self-harm
- •Patients with known hypersensitivity to paliperidone ER or to risperidone
- •Patients with a current use or known history (over the past 6 months) of substance dependence
研究组 & 干预措施
Paliperidone ER
干预措施: Paliperidone ER (Drug)
结局指标
主要结局
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
时间窗: Baseline, Week 26
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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.
次要结局
- Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score(Baseline, Week 26)
- Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score(Baseline, Week 26)
- Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score(Baseline, Week 26)
- Clinical Global Impression-Severity (CGIS)(Baseline, Week 26)
- Personal and Social Performance (PSP) Scale(Baseline, Week 26)
- Health Status as Measured by Self-rated Health Status Survey SF-36(Baseline, Week 26)
- Sleep Evaluation Scale(Baseline, Week 26)
- Daytime Drowsiness Evaluation Scale(Baseline, Week 26)