Evaluation of Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotic Medications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia
研究概览
简要总结
Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks.
The hypothesis is that they will improve and have fewer side effects.
详细描述
Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication because of poor response or unacceptable side effects.
After signing consent and having a baseline assessment they will, if necessary, be reduced to one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can be increased to 240mg after three weeks if necessary.
The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI), Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG and weight and blood metabolic measures.
The hypothesis is that ziprasidone will be generally effective and that side effects especially metabolic indices will be reduced.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia or schizoaffective
- •Capacity to give consent
- •Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age
排除标准
- •Repeated non-compliance
- •Current depot medication
- •Active medical conditions
- •QTc >500msec
- •Previous non-response
- •Previous treatment with ziprasidone
研究组 & 干预措施
Experimental
Open label change to ziprasidone
干预措施: ziprasidone (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia
时间窗: Baseline to 8 weeks
Minimum score 32 (best) maximum 210 (worst)
次要结局
- Weight(8 weeks)
- Fasting Glucose(8 weeks)
- Cholesterol(8 weeks)
- Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.(8 weeks)
- Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia(8 weeks)
- Simpson-Angus Scale Measures Drug Induced Parkinsonism(8 weeks)
- Barnes Akathisia Scale(8 weeks)
- HbA1c(8 weeks)
- Antipsychotic Medication Costs(8 weeks)
- Corrected QT Interval (QTc)(8 weeks)
- Brief Assessment of Cognition in Schizophrenia (BACS)(8 weeks)
- Calgary Depression Scale for Schizophrenia(8 weeks)
- Personal Evaluation of Transitions in Treatment Scale (PETiTP(8 weeks)
- Insulin Level(8 weeks)
- Medical Outcomes Study Cognitive Functioning Scale (MOS-COG)(8 weeks)
研究者
Nigel Bark MD
Director of Scizophrenia Research
Bronx Psychiatric Center