ITI-007 (Lumateperone Tosylate) for Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Schizophrenia Symptoms
研究概览
简要总结
The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.
详细描述
Patients will be started on ITI-007 and current medication will be slowly discontinued within the first 7 days of starting ITI-007, with some flexibility allowed if clinically indicated. No patients will be left unmedicated because of this study.
Patients will be seen weekly for the first 4 weeks, biweekly for the second month and then monthly for six months. Patients will be monitored by clinical and safety rating scales, and will be required to show improvement after 3 months to remain in this study. Patients not improving at this time will be assessed for the risks/benefits of continuing.
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
盲法说明
None (open label)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
- •Has capacity to provide informed consent
- •Medically stable for study participation
- •Judged clinically not to be at significant suicide or violence risk
- •Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)
排除标准
- •Substance abuse within last 90 days
- •ECG abnormality that is clinically significant
- •Pregnancy, lactation, or lack of use of effective birth control
- •Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
- •Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers
- •History or presence of concomitant major psychiatric illness.
- •Use of other antipsychotic medications at baseline.
- •Use of another investigational medication in the previous 4 weeks
研究组 & 干预措施
ITI-007
Open-Label ITI-007 40-60 mg
干预措施: ITI-007 (Drug)
结局指标
主要结局
Schizophrenia Symptoms
时间窗: Change from baseline in Total PANSS score after 6 month treatment
schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.
次要结局
未报告次要终点
研究者
Jeffrey A. Lieberman, MD
Director, New York State Psychiatric Institute
New York State Psychiatric Institute