NCT00634348已完成4 期
A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with schizophrenia or schizoaffective disorder
- •At least a 6th grade reading level
- •Males or females, between 18 and 70 years of age at the time of consent
- •Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening
排除标准
- •Psychiatric disorder other than schizophrenia or schizoaffective disorder
- •History of arrhythmia, heart attack, or heart failure
研究组 & 干预措施
Aripiprazole
Active Comparator
干预措施: Aripiprazole (Drug)
Ziprasidone
Active Comparator
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
时间窗: 28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
时间窗: 28 days
次要结局
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.(28 days)
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.(28 days)
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.(28 days)
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.(28 days)
- Change from baseline to endpoint in Patient Preference Scale (PPS) scores.(28 days)
- Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.(28 days)
- Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.(28 days)
- Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.(28 days)
- Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.(28 days)
- Change from baseline to endpoint in Life Skills Profile (LSP).(28 days)
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.(28 days)
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.(28 days)
- Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.(28 days)
- Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.(28 days)
- Change from baseline to endpoint in Cognitive Battery.(28 days)
- Change from baseline to Day 28 in movement disorder rating scale scores.(28 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese PatientsSchizophreniaNCT00645372Pfizer's Upjohn has merged with Mylan to form Viatris Inc.242
终止
4 期
Ziprasidone And Olanzapine's Outcomes In ManiaAcute ManiaBipolar Disorder, ManicNCT00329108Pfizer's Upjohn has merged with Mylan to form Viatris Inc.29
已完成
4 期
Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective DisorderPsychotic DisordersSchizophreniaNCT00137020Pfizer's Upjohn has merged with Mylan to form Viatris Inc.294
已完成
3 期
Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute SchizophreniaSchizophreniaNCT00712686Otsuka Pharmaceutical Development & Commercialization, Inc.690
已完成
3 期
A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic DrugsSchizophreniaNCT00649844Pfizer's Upjohn has merged with Mylan to form Viatris Inc.147
