A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 主要终点
- score of HAMD
研究概览
简要总结
Through self-controlled studies on metabolic syndrome related indicators, efficacy and other adverse reactions in patients with schizophrenia who developed metabolic syndrome after treatment with other antipsychotics, switched to Zoladine capsules (ziprasidone hydrochloride capsules). To evaluate the clinical application value of switching to Zolodine for schizophrenia patients with metabolic syndrome, and to explore the drug selection strategy for long-term treatment of schizophrenia patients.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the DSM-IV diagnostic criteria for schizophrenia, patients aged 18-40 years old have been treated with other antipsychotics for more than 8 weeks (inclusive) before being included, meet the diagnostic criteria for metabolic syndrome (IDF, 2005), and have not reached diabetes , Patients with diagnostic criteria for hypertension.
排除标准
- •Female patients who are pregnant or breastfeeding;
- •Serious and unstable physical diseases, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, nerve, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures;
- •Patients with refractory schizophrenia;
- •Those who meet the DSM-IV standards for dementia or substance dependence (except tobacco);
- •Patients with a history of contraindications to ziprasidone or intolerance of ziprasidone;
- •Patients who use long-acting antipsychotic injections or oral medications;
- •Patients who have recently experienced prolonged QT interval, acute myocardial infarction, and decompensated heart failure;
- •Patients have recently taken drugs that can prolong the QT interval, such as dofetilide, sotalol, quinidine, other class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, Chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadone, dolastron methanesulfonate Acid, probucol or tacrolimus;
- •At the same time taking other drugs that can cause obesity, such as oral contraceptives;
- •Patients who have met metabolic syndrome before diagnosis and treatment of schizophrenia.
研究组 & 干预措施
Zolodine group
干预措施: Zolodine (Drug)
结局指标
主要结局
score of HAMD
时间窗: 2 weeks
the score of Hamilton depression scale(HAMD), the minimum and maximum values are 0 and 68, the higher scores mean a worse outcome.
score of PANSS
时间窗: 2 weeks
the score of positive and negative syndrome scale (PANSS), the minimum and maximum values are 16 and 112, the higher scores mean a worse outcome.
score of HAMA
时间窗: 2 weeks
the score of Hamilton anxiety scale(HAMA), the minimum and maximum values are 0 and 56, the higher scores mean a worse outcome.
次要结局
未报告次要终点