A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,429
- 主要终点
- Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
研究概览
简要总结
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
详细描述
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator
- •A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120
- •Signed informed consent
- •Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
- •Men must agree to use a double-barrier method of birth control
- •Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)
排除标准
- •A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
- •Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
- •A diagnosis of substance dependence within 6 months before screening
- •History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
- •Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
- •Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
- •Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Paliperidone palmitate 3-month (PP3M)
A formulation of paliperidone palmitate with a 3-month injection interval
干预措施: PP3M 175 mg eq. (Drug)
Paliperidone palmitate 3-month (PP3M)
A formulation of paliperidone palmitate with a 3-month injection interval
干预措施: PP3M 263 mg eq. (Drug)
Paliperidone palmitate 3-month (PP3M)
A formulation of paliperidone palmitate with a 3-month injection interval
干预措施: PP3M 350 mg eq. (Drug)
Paliperidone palmitate 3-month (PP3M)
A formulation of paliperidone palmitate with a 3-month injection interval
干预措施: PP3M 525 mg eq. (Drug)
Paliperidone palmitate 3-month (PP3M)
A formulation of paliperidone palmitate with a 3-month injection interval
干预措施: Placebo (20% Intralipid) (Drug)
Paliperidone palmitate 1-month (PP1M)
A formulation of paliperidone palmitate with a 1-month injection interval
干预措施: PP1M 50 mg eq. (Drug)
Paliperidone palmitate 1-month (PP1M)
A formulation of paliperidone palmitate with a 1-month injection interval
干预措施: PP1M 75 mg eq. (Drug)
Paliperidone palmitate 1-month (PP1M)
A formulation of paliperidone palmitate with a 1-month injection interval
干预措施: PP1M 100 mg eq. (Drug)
Paliperidone palmitate 1-month (PP1M)
A formulation of paliperidone palmitate with a 1-month injection interval
干预措施: PP1M 150 mg eq. (Drug)
结局指标
主要结局
Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
时间窗: Up to 48 weeks
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
次要结局
- Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48(DB Baseline (Week 17) and 48 week or DB Endpoint)
- Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48(DB Baseline (Week 17) and 48 week or DB Endpoint)
- Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria(Weeks 41 to 65)
- Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48(DB Baseline (Week 17) and 48 week or DB Endpoint)
- Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48(DB Baseline (Week 17) and 48 week or DB Endpoint)
- Change From Baseline in Marder Factor Subscale Score at Week 48(DB Baseline (Week 17) and 48 week or DB Endpoint)