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临床试验/NCT00634348
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

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

发起方
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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