NCT00406315已完成4 期
A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder
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 255 人开始时间: 2006年11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
- 255
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weight at Week 16
研究概览
简要总结
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, between 18 and 55 years of age, at the time of consent.
- •Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
- •Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
排除标准
- •Subjects who are unable to provide informed consent
- •Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
- •Females who are pregnant, breast feeding, or lactating at screening.
研究组 & 干预措施
A1
Other
atypical antipsychotic for the treatment of schizophrenia
干预措施: ziprasidone (Drug)
结局指标
主要结局
Change From Baseline in Weight at Week 16
时间窗: Baseline, Week 16, Week 16 LOCF
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
次要结局
- Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16(Baseline, Week 16)
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16(Baseline, Week 16)
- Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16(Baseline, Week 16, Week 16 LOCF)
- Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16(Baseline, Week 16, Week 16 LOCF)
- Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16(Baseline, Week 16, Week 16 LOCF)
- Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16(Baseline, Week 16)
- Change From Baseline in Fasting Glucose at Week 16(Baseline, Week 16)
- Change From Baseline in Waist and Hip Circumference at Week 16(Baseline, Week 16)
- Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16(Baseline, Week 16, Week 16 LOCF)
- Change From Baseline in Fasting Insulin at Week 16(Baseline, Week 16)
- Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16(Week 16, Week 16 LOCF)
- Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16(Baseline, Week 16)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16(Baseline, Week 16, Week 16 LOCF)
- Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16(Baseline, Week 16, Week 16 LOCF)
研究者
研究点 (1)
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