A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
研究概览
简要总结
The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key inclusion criteria include:
- •Have a current diagnosis of schizophrenia.
- •Increase in symptoms over the past 2-4 weeks.
- •Willing to remain inpatients for the duration of the trial.
排除标准
- •Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
- •Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
- •Subjects with a history of treatment resistant schizophrenia
- •Females of childbearing potential
研究组 & 干预措施
A2
干预措施: PF-00217830 (Drug)
A5
干预措施: Placebo (Other)
A4
干预措施: Aripiprazole (Drug)
A3
干预措施: PF-00217830 (Drug)
A1
干预措施: PF-00217830 (Drug)
结局指标
主要结局
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
时间窗: 5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
时间窗: 5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
时间窗: Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
时间窗: 5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
时间窗: 4 weeks
次要结局
- PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)(Screening, Day 1, 3, 7, 14 and 21)
- PANSS positive, negative, and general psychopathology subscales(Screening, Day 1, 3, 7, 14 and 21)
- Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)(Screening and Days 1, 3, 7, 14 and 21)
- NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.(Days 1 and 21)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Day 21)
- Pharmacokinetics(Days 7, 14, 20, 21, before discharge and Followup)
- PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)(Screening and Days 1, 3, 7, 14 and 21)