An Open Label Trial of Ziprasidone as an Adjuvant for Clozapine- or Olanzapine-Associated Diabetes Mellitus or Impaired Fasting Glucose in Chronic Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change From Baseline in Fasting Glucose
研究概览
简要总结
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.
详细描述
Specific Aims:
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder.
STUDY PROCEDURES:
We have designed this trial to examine effects upon weight, lipids and glucose metabolism along with positive symptoms, negative symptoms, and depressive symptoms during a six-week open label study.
Location:
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
- 是
入选标准
- •Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- •Ages 18-65 years
- •Capable of providing informed consent
- •Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or insulin resistance
- •Stable dose of clozapine or olanzapine for at least 1 month
- •Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant side effects
排除标准
- •Serious medical or neurological illness (unstable cardiac disease including recent myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal impairment, etc.)
- •Current substance abuse
- •Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- •History of serious blood dyscrasia requiring discontinuation of clozapine
- •Serious suicidal or homicidal risk within the past six months
- •History of diabetes mellitus prior to treatment with clozapine or olanzapine
- •H/o prolongation of QTc interval (>450) on EKG or clinically significant EKG abnormalities.
- •Treatment with medications that significantly prolong QTc interval such as dofetilde, sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate, dolasetron myselate, probucol, or tacrolimus.
结局指标
主要结局
Change From Baseline in Fasting Glucose
时间窗: baseline, week 6
Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)
Change From Baseline on Fasting Insulin
时间窗: baseline, week 6
Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)
次要结局
未报告次要终点
研究者
David C. Henderson, MD
Associate Professor of Psychiatry
Harvard Medical School (HMS and HSDM)