Olanzapine in Standard Clinical Practice. 6-month Efficacy and Safety Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Change in scales' ratings to assess efficacy
研究概览
简要总结
This clinical observational study aims to investigate the efficacy of olanzapine (Villamos ®) in accordance with the instructions attached thereto in standard clinical practice, followed by the physician to the patient.
This is a multicenter, non- interventional observational study , 6-month period without preparing the patient to take the usual his medication . A total of 3 scheduled visits : Visit 1 to Day 0 ( integration , base ) , Visit 2 at month 3 and Visit 3 at month 6 ( = end of treatment) .
The purpose of the study is to demonstrate the efficacy and safety of olanzapine in patients who are indicated . Will be monitored and recorded all the different concomitant therapy . The treatment of each patient is an individual designated by the physician , according to standard clinical practice and without any intervention research purpose .
During the six months of observation patients visit the clinic at the beginning (day 0 ), intermediate ( 3 months ) and end (month 6). The purpose of these visits is regularly monitored by their doctor for senile dementia and their behavior .
详细描述
Schizophrenia
Treatment may be divided as follows :
Treating first episode- Treatment of acute- Maintenance therapy , relapse prevention - Treatment -resistant schizophrenia Treating first episode
• The oral antipsychotics ( APS ) second generation ( atypical ) considered the treatment of choice : olanzapine , risperidone , quetiapine , aripiprazole , ziprasidone , amisulpride , paliperidone
- Sertindole used in patients who can not tolerate at least one of the remaining APS
- Advantages monotherapy
- The dose of medication ( FA ) is preferable to the lower limits of normal dose as defined
- The appropriate duration of therapy should be continued for 12-24 months after the recession of the episode .
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and over
- •Diagnosis of schizophrenia (DSM-IV-DR)
- •Maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response .
- •Treatment of moderate to severe manic episode .
- •Patients whose manic episode has responded to olanzapine treatment ,
- •for the prevention of recurrence in patients with bipolar disorder (DSM-IV-)
- •The patient has a reliable caregiver
- •Signed consent form to participate in the study after informed by reliable caregiver of the patient or other witness
- •The patient is treated with olanzapine before joining the present study
- •The patient had conformability to study
排除标准
- •Hypersensitivity to the active substance or to any of the ingredients.
- •Patients with known risk for narrow-angle glaucoma .
- •Dementia-related psychosis and / or behavioral disturbances
- •Disease Parkinson
- •Neuroleptic Malignant Syndrome (NMS)
- •Patients with low leukocyte and / or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia ,
- •Clinically significant laboratory and ECG abnormalities .
- •Participation in another clinical study than this
- •Refusal to sign the consent form to participate in the study after informed by reliable caregiver of the patient or other witness
- •The patient is treated with olanzapine before joining the clinical trial
结局指标
主要结局
Change in scales' ratings to assess efficacy
时间窗: baseline, 3 months, 6 months
change in PANSS rating change in Y-MRS rating change in CES-D rating
次要结局
- Safety assessment(baseline, 3 months, 6 months)