NCT01760889终止3 期
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
研究概览
简要总结
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
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
- •- 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 Low Dose Range
Experimental
干预措施: SPD489 low dose range (40mg, 80mg, and 100mg) (Drug)
SPD489 High Dose Range
Experimental
干预措施: SPD489 high dose range (120mg, 140mg and 160mg) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
时间窗: Baseline and 26 weeks
次要结局
- Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks(Baseline and 26 weeks)
- Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale(Baseline and week 26)
- Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale(Up to 26 weeks)
- Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks(Baseline and 26 weeks)
- Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks(Baseline and 26 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 26 weeks)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks(Baseline and 26 weeks)
研究者
研究点 (4)
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