NCT01446328已完成4 期
Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study
Haukeland University Hospital4 个研究点 分布在 2 个国家目标入组 151 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 4
- 主要终点
- Change of the Positive and Negative Syndrome Scale total score
研究概览
简要总结
In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses and followed for 12 months. The study is independent of the pharmaceutical industry, and in accordance with a pragmatic design a clinically relevant sample will be included with as few exclusion criteria as possible. The patients will be assessed repeatedly with regards to symptoms, side effects, and cognitive functioning, as well as laboratory parameters. The study hypothesis is that clinically meaningful differences among the drugs will be disclosed in a pragmatic design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A:The observational cohort
- •Patients 16 years old or older
- •Active psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).
- •Or ICD-10 diagnosis corresponding to psychotic disorders or other mental disorders with psychotic features (F10-F19: .5 (psychotic disorder); F20-F29, F30.2, F31.2, F31.5, F32.3, F33.3). From which eligible patients are recruited to the B:The pragmatic, randomized, controlled trial (The Best Intro Study)
- •Patients 18 years and older
- •Schizophrenia spectrum and delusional disorder
- •Symptoms of psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).
排除标准
- •Inability to understand spoken Norwegian.
- •Patients with organic psychosis due to limbic encephalitis detected by antibodies in serum obtains at inclusion (such as NMDAR, VGKC and paraneoplastic antibodies performed at the Neuroimmunology Laboratory, Department of Neurology, Haukeland University Hospital) Pregnant or breast feeding women.
- •Aripiprazole: Hypersensitivity to the active substance or to any of the excipients
- •Amisulpride: Hypersensitivity to the active ingredient or to other ingredients of the medicinal product; concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaeochromocytoma; lactation, combination with the following medications which could induce torsade de pointes: Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide. Class III antiarrhythmic agents such as amiodarone, sotalol. Other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin. Combinations with levodopa.
- •Olanzapine: Hypersensitivity to the active substance or to any of the excipients. Patients with known risk of narrow-angle glaucoma.
研究组 & 干预措施
Aripiprazole
Active Comparator
干预措施: Aripiprazole (Drug)
Olanzapine
Active Comparator
干预措施: Olanzapine (Drug)
Amisulpride
Active Comparator
干预措施: Amisulpride (Drug)
结局指标
主要结局
Change of the Positive and Negative Syndrome Scale total score
时间窗: 12 months
次要结局
- Change of systolic blood pressure(12 months)
- Change of the Global Assessment of Functioning scale(12 months)
- Change of the positive subscale scores of the Positive and Negative Syndrome Scale(12 months)
- Change of serum High Density lipoprotein(12 months)
- Change of the UKU Side Effects Rating Scale - Patient version score(12 months)
- Change of serum total cholesterols(12 months)
- Change of prolactin(12 months)
- Change of the rate-corrected QT interval at electrocardiogram(12 months)
- Change of the negative subscale scores of the Positive and Negative Syndrome Scale(12 months)
- Change of the general subscale scores of the Positive and Negative Syndrome Scale(12 months)
- Change of serum Low Density lipoprotein(12 months)
- Change of the Clinical Global Impression - Severity of Illness score(12 months)
- Change of serum triglycerides(12 months)
- Change of serum fasting glucose(12 months)
- Change of waist circumference(12 months)
- Change of diastolic blood pressure(12 months)
- Change of hip circumference(12 months)
- Change of body mass index(12 months)
研究者
研究点 (4)
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