A 12-week , Randomized, Phase 2, Double-blind, Parallel-group Study Of Two Dose Levels Of Pf-02545920 Compared To Placebo In The Adjunctive Treatment Of Outpatients With Sub-optimally Controlled Symptoms Of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 240
- 试验地点
- 41
- 主要终点
- Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline
研究概览
简要总结
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 from baseline compared to placebo.
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
- •Psychiatrically stable subjects with schizophrenia who have had a suboptimal response to current treatment
- •Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
- •Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.
排除标准
- •History of seizures or of a condition with risk of seizures.
- •Subjects with schizophrenia that have not responded at all to current treatment.
- •Pregnant or nursing females, and females of child bearing potential.
研究组 & 干预措施
PF-02545920 (5mg)
干预措施: PF-02545920 (Drug)
Placebo
干预措施: Placebo (Drug)
PF-02545920 (15mg)
干预措施: PF-02545920 (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline
时间窗: Baseline
The Positive and Negative Syndrome Scale (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.
Change From Baseline to Week 12 in PANSS Total Score
时间窗: Baseline, Week 12
The 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 to Week 12 in Personal and Social Performance Scale (PSP) Total Score(Baseline, Week 12)
- Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales(Baseline, Week 12)
- Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores(Baseline, Week 12)
- Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)(Baseline, Week 12)
- Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12(Week 12)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)(Baseline up to 7-10 days after last dose of study drug (follow-up))
- Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria(Screening up to 7-10 days after last dose of study drug (follow-up))
- Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria(Screening/Baseline up to Week 12 (or Early Termination))
- Number of Participants With Weight Change >=7%(Screening up to Day 84)
- Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site(Baseline and Week 12 or Early Termination)
- Number of Participants With Laboratory Test Abnormalities(Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only))
- Number of Participants With Extrapyramidal Motor System (EPS) AEs(Baseline up to 7-10 days after last dose of study drug (follow-up))
- Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12(Baseline; Weeks 6 and 12)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12(Baseline; Weeks 6 and 12)
- Change From Baseline in Insulin at Weeks 6 and 12(Baseline; Weeks 6 and 12)
- Change From Baseline in Prolactin at Weeks 6 and 12(Baseline; Weeks 6 and 12)
- Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)(Baseline, Week 12)
- Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period(Active treatment period (Weeks 1 to 12/Early Termination))
- Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline up to 7-10 days after last dose of study drug)
- Concentration of PF-02545920 and Its Metabolite, PF-01001252(Days 14, 28, 42, 56, 70, 84/Early Termination)