PER-041-00已完成未知
Change from Haloperidol to Olanzapine in schizophrenic patients: an open study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Women or men, from 18 to 65 years of age in the visit 1.
- •Female patients with gestational potential should use a medically accepted means of contraception.
- •Each patient must have a sufficient level of understanding to communicate intelligently with the researcher, nurse and study coordinator.
- •Patients must be reliable. They must agree to cooperate with all the tests and exams required by the protocol.
- •Each patient (or authorized legal representative of the patient) must understand the nature of the study and sign an informed consent.
- •Patients must meet the criteria for schizophrenia defined in the DSMIV.
- •Patients must have been treated with haloperidol for a minimum of 6 weeks before entering the study.
- •Patients must have a total SAS score of> 3.
排除标准
- •Women who are pregnant or nursing.
- •Severe illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinological, neurological, immunological or hematological diseases, such as anticipating hospitalization within 3 months or death within 3 years.
- •Hyperthyroidism or hyperthyroidism uncorrected.
- •Acute angle glaucoma.
- •One or more attacks without a clear and determined etiology. Leukopenia or history of leukopenia without a clear and determined etiology.
- •History of severe allergies or adverse reactions to multiple medications.
- •Abuse or dependence of any substance (alcohol or other drugs) within the previous 3 months.
- •Judged clinically as seriously at risk of suicide.
- •Participation in a clinical trial of another research substance within 1 month (30 days) before entering the study (visit 1).
- •Any other medication concomitant with primary activity of the central nervous system, different from that specified in section 3.8.
- •Treatment with a neuroleptic injectable deposit prior to visit 1.
- •Previous exposure to olanzapine.
- •Treatment with lithium, anticonvulsants, benzodiazepines, antidepressants (except fluoxetine), psychostimulants, reversible monoamine oxidase monoamine oxidase inhibitors, reserpine, guanethidine or guanadrel, within week 1 before visit 2.
- •Any patient treated with clozapine within 4 weeks prior to visit 2.
- •Treatment with inhibitors of the non-reversible monoamine oxidase within 2 weeks prior to visit 2.
- •Fluoxetine treatment within 4 weeks prior to visit 2.
- •The use of anticholinergics as prophylaxis is prohibited.
- •More than 20 mg. of haloperidol the last 2 days before the visit 2.
研究者
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