A Phase 2, Multicenter, Double-blind, Randomized, Parallel Group, 4-week Inpatient Study To Evaluate The Safety And Efficacy Of Two Fixed Doses Of Pf-02545920 Compared To Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia Using Risperidone As An Active Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 259
- 试验地点
- 43
- 主要终点
- Proportion of Participants With Dystonia Adverse Events
研究概览
简要总结
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.
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
- Double (Participant, Investigator)
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
- •Diagnosis of schizophrenia with acute exacerbation of illness
- •The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.
排除标准
- •Subjects with evidence or history of clinically significant uncontrolled medical illness
- •Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
- •Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
研究组 & 干预措施
PF-02545920 5 mg
干预措施: PF-02545920 (Drug)
PF-02545920 15 mg
干预措施: PF-02545920 (Drug)
Placebo
干预措施: Placebo (Drug)
Risperidone 3 mg
干预措施: Risperidone (Drug)
结局指标
主要结局
Proportion of Participants With Dystonia Adverse Events
时间窗: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)
Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
时间窗: Baseline, Week 4
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
次要结局
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4(Baseline, Week 4)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Score(Week 4)
- Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)(Baseline up to end of study (7 to 10 days after administration of last dose of study medication))
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4(Baseline, Week 4)
- Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)(Day 1 up to Week 4)
- Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4(Baseline, Week 4)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4(Baseline, Week 4)
- Change From Baseline in Abdominal Girth at Week 4(Baseline, Week 4)
- Number of Participants With Clinically Significant Changes in Physical Examinations(Screening, Week 4)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4(Baseline, Week 4)
- Clinical Global Impression - Improvement (CGI-I) Score(Week 4)
- Change From Baseline in Body Weight at Week 4(Baseline, Week 4)
- Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4(Baseline, Week 4)
- Number of Participants With Laboratory Test Abnormalities(Screening up to end of study (7 to 10 days after administration of last dose of study medication))
- Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin(Day 1 up to Week 4)
- Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication))
- Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4(Baseline, Week 4)