A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
研究概览
简要总结
The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.
详细描述
Not required
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
- •18 to 65 years of age
- •Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
- •Fixed home/place of residence and can be reached by telephone
- •On a stable dose of antipsychotic medications
- •Able to swallow capsules
排除标准
- •-Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
- •Treated with clozapine in past 30 days
- •Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
- •History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
- •Uncontrolled hypertension
- •History of thyroid disorder that has not been stabilized on thyroid medication
- •Pregnant or nursing
- •Subject has received an investigational product or participated in a clinical study within 30 days
研究组 & 干预措施
SPD489
干预措施: SPD489 (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
时间窗: Basline and 52 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks
时间窗: Baseline and 52 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks
时间窗: Baseline and 52 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks
时间窗: Baseline and 52 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks
时间窗: Baseline and 52 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to 52 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks
时间窗: Baseline and 52 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks
时间窗: Baseline and 52 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks
时间窗: Baseline and 52 weeks
次要结局
- Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks(Baseline and 52 weeks)
- Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks(Baseline and 52 weeks)
- Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale(Baseline and week 52)
- Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale(Up to 52 weeks)
- Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks(Baseline and 52 weeks)