Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
研究概览
简要总结
This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).
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
- •Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
- •Has a diagnosis of schizophrenia
- •Is clinically stable
- •Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
- •Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
- •Agreed to abide by the contraceptive requirements o the protocol
- •Resides in a stable living situation
- •Additional criteria may apply
排除标准
- •Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
- •Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
- •Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
- •Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
- •Additional criteria may apply
研究组 & 干预措施
Aripiprazole Lauroxil
Intramuscular (IM) injection
干预措施: Aripiprazole Lauroxil (Drug)
结局指标
主要结局
Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
时间窗: Up to 7 months
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data.
次要结局
- Number of Participants With Adverse Events(Up to 7 months)
- Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)(Up to 7 months)
- Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores(Up to 7 months)
- Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)(Up to 7 months)
- Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)(Up to 7 months)