NCT03345979已完成3 期
A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
研究概览
简要总结
This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of schizophrenia
- •Requires acute treatment for symptoms of schizophrenia
- •Willing and able to be confined to an inpatient study unit for up to 3-4 weeks
- •Has experienced at least one previous hospitalization for schizophrenia
- •Has been able to achieve outpatient status for more than 3 months in the past year
- •Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2
- •Resides in a stable living situation when not hospitalized
- •Has an identified reliable caregiver (for example, family member)
- •Additional criteria may apply
排除标准
- •Poses a current suicide risk
- •Pregnant, planning to become pregnant, or breastfeeding
- •Initiated first antipsychotic treatment within the past 12 months
- •Has received a long-acting injectable antipsychotic in the past 3 months
- •Has participated in a clinical study involving any investigational product within the past 3 months, or is currently participating in a clinical study involving an investigational product.
- •A positive urine drug test for drugs of abuse
- •Additional criteria may apply
研究组 & 干预措施
Treatment Group 1
Experimental
Regular injections
干预措施: Aripiprazole Lauroxil (Combination Product)
Treatment Group 2
Active Comparator
Regular injections
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 4
时间窗: Baseline and 4 weeks
Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
次要结局
- Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4(Baseline and 4 weeks)
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9(Baseline and 9 weeks)
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25(Baseline and 25 weeks)
- Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9(Baseline and 9 weeks)
- Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25(Baseline and 25 weeks)
- Number of Participants With Serious and Non-serious Adverse Events (AEs)(Up to 25 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.SchizophreniaNCT00790192Sumitomo Pharma America, Inc.488
暂停
1 期
Safety, Tolerability, and Pharmacokinetics of APN1125 in Subjects With SchizophreniaSchizophreniaNCT02724917CoMentis30
已完成
3 期
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic SchizophreniaChronic SchizophreniaNCT00789698Sumitomo Pharma America, Inc.240
已完成
3 期
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With SchizophreniaSchizophreniaNCT03465787Bukwang Pharmaceutical210
已完成
3 期
Lurasidone HCl A Phase 3 Study of Patients With Acute SchizophreniaSchizophreniaNCT00615433Sumitomo Pharma America, Inc.478