An Open-label, Single-arm, Multicenter, Phase IV Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- Change from Baseline in Total Personal and Social Performance (PSP) Score at Month 12
研究概览
简要总结
The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
详细描述
This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- •Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
- •To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
- •Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
- •Participants who are willing and capable to complete the questionnaires
排除标准
- •Use of clozapine, depot neuroleptics or risperidone within the last 3 months
- •Any unstable clinical condition including clinically important abnormal laboratory findings
- •Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
- •History of malignant neuroleptic syndrome
- •To be considered carrying high risk regarding adverse effects, homicide and/or suicide
研究组 & 干预措施
Paliperidone extended-release (ER)
干预措施: Paliperidone extended-release (ER) (Drug)
结局指标
主要结局
Change from Baseline in Total Personal and Social Performance (PSP) Score at Month 12
时间窗: Baseline and Month 12
The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.
次要结局
- Change from Baseline in Short Form (SF)-36 Scale Score at Month 12(Baseline and Month 12)
- Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12(Baseline and Month 12)
- Change from Baseline in Percentage of Participants With Relapse at Month 12(Baseline and Month 12)
- Change from Baseline in Global Assessment of Functioning (GAF) Score at Month 12(Baseline and Month 12)