NCT01568229终止2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
研究概览
简要总结
The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia
- •Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥ 20
- •Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30
- •Receiving stable antipsychotic therapy for at least 8 weeks prior to screening
- •Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening
- •Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study
- •The subject or subject's legally acceptable representative has provided informed consent.
排除标准
- •Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70
- •Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam
- •Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening
- •Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening
- •Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study
- •Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).
- •Other criteria may apply
研究组 & 干预措施
AMG 747 - Dose 1
Experimental
干预措施: AMG 747 (Drug)
AMG 747 - Dose 2
Experimental
干预措施: AMG 747 (Drug)
AMG 747 - Dose 3
Experimental
干预措施: AMG 747 (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
时间窗: 12 Weeks
NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint
次要结局
- Change from baseline to week 12 on the CGI-S(12 weeks)
- Change from baseline to week 12 on the PANSS total score and Marder factor scores(12 weeks)
- Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12(12 Weeks)
- CGI-I scores at week 12(12 weeks)
- Change on cognition battery(12 weeks)
- Change in personal and social functioning(12 weeks)
- Change on patient reported outcomes(12 weeks)
研究者
研究点 (1)
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