Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 6
- 主要终点
- A change in the Brief Psychotic Rating Scale (BPRS)
研究概览
简要总结
This study is designed with the aim to evaluate the clinical effect of the overlapped switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.
详细描述
Patients with schizophrenia or schizoaffective disorder were recruited in this 12-week, multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression - Severity (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding the metabolic effects of switching to ziprasidone, weight, body mass index (BMI), waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured at each follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male and female aged 18-55 years treated with risperidone, olanzapine, amisulpride, quetiapine and typical antipsychotics.
- •Both in- and outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder.
- •Their primary psychiatric clinician determined that they would benefit from a change in their medications, either because of suboptimal efficacy or because of side effects.
排除标准
- •Those who are treated with medications that prolong the QTc interval.
- •Those who have any other axis I DSM-IV diagnoses.
- •Those who have a history of substance abuse or dependence within 1 month.
- •Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
- •Those who have a past history of hypersensitivity or intolerance to ziprasidone.
- •Those who have history of clozapine use within 1 month.
- •Those who participated in clinical trials within 1 month before entering the study entry.
- •Those who have used depot antipsychotics within one cycle before entering the study.
- •Those who are pregnant or are breast feeding.
- •Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
- •The patients unable/unlikely to comprehend/follow the protocol.
研究组 & 干预措施
Ziprasidone
During the 12-week study period, patients were prescribed ziprasidone at 20 to 160 mg/day flexibly based on their effectiveness and tolerability. Fifty to one hundred percent of the past antipsychotic dose was maintained in the first week; during next 3 weeks, flexible dosing of 0-100% was used; then, ziprasidone was discontinued. This study included four visits: baseline, week 4, week 8, and week 12. Concomitant benzodiazepines (oral formula or injection) were allowed up to a dose of 4 mg of lorazepam-equivalents per day for anxiety and agitation.
干预措施: Ziprasidone (Drug)
结局指标
主要结局
A change in the Brief Psychotic Rating Scale (BPRS)
时间窗: baseline and 12 weeks
次要结局
- A change in the Body Mass Index (BMI)(baseline and 12 weeks)
- Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein(12 weeks)
- Urinalysis(12 weeks)
- A change in the Waist-to-hip ratio(baseline and 12 weeks)
- Electrocardiogram (ECG)(12 weeks)
- A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)(baseline and 12 weeks)
- UKU side effect rating scale - patient (UKU-SERS-Pat)(12 weeks)
- A change in the Clinical Global Impression (CGI)(Baseline and 12 weeks)
- A change in the Global Assessment of Functioning (GAF)(Baseline and 12 weeks)
研究者
Han Yong Jung
Professor
Soonchunhyang University Hospital