EUCTR2004-001041-15-LV进行中（未招募）不适用
MULTICENTRE, DOUBLE-BLIND, RISING DOSE PARALLEL GROUP STUDY OF THE EFFICACY AND TOLERABILITY OF OCAPERIDONE VERSUS OLANZAPINE IN SCHIZOPHRENIC PATIENTS
euro3d0 个研究点目标入组 90 人开始时间: 2004年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Schizophrenic patients according to DSM IV-TR diagnosis and presenting two of the following manifestations: 1)delusions; 2)hallucinations; 3)disorganised speech (e.g., frequent derailment or incoherence); 4)grossly disorganised or catatonic behaviour; 5)negative symptoms, i.e., affective flattening, alogia, or avolition;
- •-Patients presenting symptoms for at least one year.
- •-Patients presenting an exacerbation: minimum total score of 60 on PANSS (score higher or equal to 60) and a score of 4 or more on any two of the following three items of positive symptoms scale:
- •P1 Delusions
- •P3 Hallucionatory behaviou
- •P6 Suspiciousness/ persecution
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients who did not respond to 3 different anti-psychotic treatments at recommended doses for at least 3 months each;
- •-Clinically significant laboratory abnormality or disease which, in the opinion of the investigator, might create risk for the patient, obscure the effects of study treatment, or interfere with drug absorption, metabolism or excretion;
- •-Any patient having taken olanzapine within the last year
- •-Serious risk of suicide evaluated according to the investigator
研究者
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