NCT00137020已完成4 期
A Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.27 个研究点 分布在 9 个国家目标入组 294 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 27
- 主要终点
- The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
研究概览
简要总结
The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
- •Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert
排除标准
- •Resistance to conventional antipsychotic drugs
- •With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug
结局指标
主要结局
The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
次要结局
- Clinical Global Impression Improvement (CGI-I)
- Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
- Change from baseline in scores on the MADRS Without Items 4, 5
- Change from baseline in Global Assessment of Functioning (GAF)
- Change From Baseline In Drug Attitude Inventory (DAI)
- Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
- Change From Baseline in Barnes Akathisia Scale (BAS)
- Change From Baseline In Clinical Global Impression Severity (CGI-S)
- Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score
- Change From Baseline In Prolactin And Lipid Levels
- Change From Baseline In Weight
研究者
研究点 (27)
Loading locations...
相似试验
已完成
4 期
Effectiveness of Ziprasidone for Patients With SchizophreniaSchizophreniaSchizoaffective DisorderNCT01198353Soonchunhyang University Hospital67
已完成
4 期
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized PatientsSchizophreniaNCT00634348Pfizer's Upjohn has merged with Mylan to form Viatris Inc.256
撤回
4 期
Ziprasidone vs Standard Therapy for Agitated Patients in the EDPsychosisAgitationDeliriumNCT00786318George Washington University
终止
3 期
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I DisorderBipolar DisorderNCT02075047Pfizer's Upjohn has merged with Mylan to form Viatris Inc.171
已完成
4 期
Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)SchizophreniaNCT00418171Pfizer18,239