A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 323
- 主要终点
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as compared with placebo in the treatment of participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self).
详细描述
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (comparing the response in two groups of participants receiving different treatments), fixed-dose, multi-center (when more than one hospital or medical school team work on a medical research study) study of paliperidone palmitate in participants with schizophrenia. The study will consist of 3 periods: an up to 2-week pre-observation (screening) period, a double-blind period from Day 1 (baseline) to Week 13 (end of double-blind period) assessment, and a post-observation period starting after the Week 13 assessment to Week 21. For participants who discontinue the study before the last assessment in Week 13, the post-observation period will start after the discontinuation from double-blind period assessment with follow-up visits at 4, 8, and 12 weeks after the last injection. After completion of the double-blind period (Week 13), discontinuation of double-blind period treatment or withdrawal from the study, participants may receive treatment consistent with the usual standard of care. The total duration of the study will be 21 weeks, including the double-blind and post-observation periods. Participants will be randomly assigned to 1 of 2 treatment groups in a 1:1 ratio (intramuscular injections of either paliperidone palmitate or matching placebo). Injections of paliperidone palmitate or placebo will be given at Day 1 and at Weeks 1, 5, and 9 by a study drug manager and/or injector. For those participants receiving paliperidone palmitate, the Day 1 injection will be 150 milligram equivalent (mg eq.) paliperidone palmitate, followed by 100 mg eq. injections of paliperidone palmitate at Week 1, and 75 mg eq. injections of paliperidone palmitate at Weeks 5 and 9. Participants randomly assigned to placebo will receive injections matching the paliperidone palmitate injections on the same days. Efficacy will be assessed using Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Severity (CGI-S). Participant's safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants meeting Diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision
- •Women had to be: postmenopausal (for at least 2 years), surgically sterile (had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (as judged by the investigator; per local regulations), or if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel], male partner sterilization) as local regulations permitted, before entry, and had to agree to continue to use the same method of contraception throughout the study
- •A Positive and Negative Syndrome Scale (PANSS) total score at screening and at baseline (Day 1) of 60 to 120
- •Documented history of exposure to either a risperidone formulation or a paliperidone formulation and known to be tolerated before baseline (Day 1) (Even if the participant's experience of taking risperidone or paliperidone cannot be confirmed at the time of informed consent, the participant will be able to meet this criterion if the participant takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or more for at least 4 days between the day of informed consent and the day before baseline, and it is possible to confirm that there is no lack of tolerability in the participant)
- •Women of childbearing potential must have a negative beta human chorionic gonadotropin pregnancy test at the screening urine pregnancy test
排除标准
- •Primary active Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision Axis I diagnosis other than schizophrenia
- •A Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- •Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
- •History or current presence of neuroleptic malignant syndrome or tardive dyskinesia
- •Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, Intralipid, or any of their excipients (including egg yolks, soybean oil, phospholipids, and glycerol)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Paliperidone palmitate
干预措施: Paliperidone palmitate (Drug)
结局指标
主要结局
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation
时间窗: Baseline and Week 13 or early discontinuation
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.
次要结局
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation(Baseline and Week 13 or early discontinuation)
- Participants With Response to the Treatment as Per PANSS Total Score.(up to Week 13 or early discontinuation)
- Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation(Baseline and Week 13 or early discontinuation (ED))
- Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation(Baseline and Week 13 or early discontinuation)
- Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation(Baseline and Week 13 or early discontinuation)
- Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation(Baseline and Week 13 or early discontinuation)