Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
研究概览
简要总结
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia
详细描述
Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia: Current symptoms were to be present for at least 7 days before screening.
- •At the Screening and Baseline visits, subjects must have had a Brief Psychiatric Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization.
- •Age 13 - 17 years
排除标准
- •Imminent risk of suicide or homicide, as judged by the site investigator
- •Any history of serious or unstable medical illness, including risk for QT prolongation
研究组 & 干预措施
2.0
干预措施: placebo (Drug)
1.0
干预措施: Ziprasidone oral capsules (Drug)
结局指标
主要结局
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
时间窗: Baseline, Week 6
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
次要结局
- Change From Baseline in Children's Global Assessment Scale (CGAS)(Baseline, Week 2, Week 4, Week 6, Early termination (ET))
- Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score(Baseline, Week 1 through Week 6)
- Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13(Baseline, Week 1 through Week 6)
- Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)(Baseline, Week 1 through Week 6)
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6(Baseline, Week 6)
- Clinical Global Impression of Improvement (CGI-I) Score at Week 6(Baseline, Week 6)
- Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score(Baseline, Week 1 through Week 6)
- Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score(Baseline, Week 1 through Week 6)
- Number of Subjects Per Response on the School Placement Questionnaire: School Situation(Baseline, Week 2, Week 6, ET)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6(Baseline, Week 6)
- Change From Baseline in PANSS: Positive and Negative Subscales at Week 6(Baseline, Week 6)
- Change From Baseline in Child Health Questionnaire (CHQ)(Baseline, Week 6, ET)
- Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1(Baseline, Week 2, Week 6)
- Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales(Baseline, Week 6, ET)
- Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index(Baseline, Week 6, ET)
- Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item(Baseline, Week 1 through Week 6)
- Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance(Baseline, Week 2, Week 6, ET)
- Number of Subjects Per Response on the School Placement Questionnaire: School Attendance(Baseline, Week 2, Week 6, ET)