NCT00567203已完成1 期
A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in the CNS Vital Signs Cognition Battery composite score
研究概览
简要总结
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia
- •In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
- •Stable symptoms of schizophrenia for at least 3 months.
排除标准
- •Subjects with a psychiatric disorder other than schizophrenia
- •Substance dependence or abuse
- •Women who have child bearing potential.
研究组 & 干预措施
1
Experimental
干预措施: PF-3463275 (Drug)
2
Experimental
干预措施: PF-3463275 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the CNS Vital Signs Cognition Battery composite score
时间窗: 6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
时间窗: 38 days
Pharmacokinetics of PF-3463275
时间窗: 6 days
次要结局
- Positive and Negative Syndrome Scale (PANSS)(6 days)
- Change from baseline in the CNS Vital Signs Cognition Battery domain scores(6 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)Retinitis PigmentosaNCT02110225Dompé Farmaceutici S.p.A50
已完成
2 期
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective DisorderTardive DyskinesiaNCT01393600Neurocrine Biosciences37
已完成
2 期
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Chronic Lymphocytic LeukemiaNCT00963105Celgene104
已完成
2 期
Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)DementiaAlzheimer's DiseaseNCT00104273Teva Branded Pharmaceutical Products R&D, Inc.376
已完成
1 期
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge ModelMalariaNCT01397227Crucell Holland BV36