NCT00324051已完成4 期
PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 9
- 主要终点
- Patient preference measured by a simple preference question.
研究概览
简要总结
The purpose of the study is to estimate drug preference of stable schizophrenic patients who will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine tablets for 6 weeks and vice-versa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •You are an outpatient diagnosed with stable schizophrenia.
- •You are a male or female in the age of 18 to 65 years old.
- •You are retrospectively judged by investigators, based on clinical interview and impression, to have been stable for at least 4 weeks.
- •You must be able to take olanzapine orodispersible in a single daily dose.
- •You are treated with conventional oral olanzapine tablet (as monotherapy) for at least 1 month.
排除标准
- •You have used olanzapine in the past and are no longer using it because of a bad reaction.
- •You have known Human immunodeficiency virus positive (HIV+) status.
- •You have known uncorrected, narrow angle glaucoma.
- •You have known Leukopenia, (abnormally low white blood cell count).
- •You have a serious or uncontrolled illness (for example: liver disease, history of heart disease, or inadequately controlled diabetes.)
- •You have Parkinson's disease.
- •You are a female patient who is either pregnant or nursing
- •You are taking medications that are not allowed in the study.
结局指标
主要结局
Patient preference measured by a simple preference question.
次要结局
- Safety and tolerability as measured by AMDP-5
- Determine the predictors of drug compliance
- Compare serum ghrelin levels
- Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)
- Mean change from baseline to endpoint in body mass index (BMI)
- Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)
- Patient preference of the paranoid sub population as measured by a simple preference question
- Better treatment adherence as measured by DAI-10
研究者
研究点 (9)
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