A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 主要终点
- Change in PANSS-EC From Baseline
研究概览
简要总结
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of Staccato Loxapine or placebo in treating acute agitation in patients with schizophrenia or bipolar disorder (manic or mixed episodes) as defined by DSM-V criteria.Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
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
- •Male and female patients between the ages of 18 to 65 years, inclusive.
- •Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder.
- •Patients are judged to be clinical mild to moderate agitation at baseline with a total value of ≥ 14, and have a score ≥4 on at least 1 of 5 items on the PANSS-EC scale, and with a value of ≥3 on CGI-S scale.
- •Patients are judged to be cooperative by the Investigator.
- •Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained.
排除标准
- •Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment).
- •Patients judged to be at serious risk for suicide as per the Investigator's judgement.
- •Patients with a history of allergy or intolerance to loxapine or amoxapine.
- •Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding.
- •Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
- •Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device.
研究组 & 干预措施
Inhaled loxapine
Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
干预措施: Inhaled loxapine (Drug)
Inhaled placebo
Inhaled placebo, may repeat x 1 or 2 after 2 hours
干预措施: Inhaled placebo (Drug)
结局指标
主要结局
Change in PANSS-EC From Baseline
时间窗: Time Frame: Baseline and 2 hours
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
次要结局
- Change in PANSS-EC From Baseline(Baseline and 24 hours)