A Randomized Double-blind Controlled Trial to Assess the Benefits of Olanzapine and Amisulpride Combination Treatment in Acutely Ill Schizophrenia Patients. - COMBINE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 21
- 主要终点
- Symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS)
研究概览
简要总结
A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.
详细描述
Polypharmacy in antipsychotic therapy is an important issue when treating patients with schizophrenia. It is not well confirmed that a combination of two antipsychotic drugs lead to therapeutic benefit in contrast to monotherapy. However there is a highly frequent practice of combining atypical non-clozapine treatment that could be due to potential benefits when seeking alternatives to a high rate of non-response in acute phase. Therefore there is a need for further trials of sufficient power to address efficacy and safety issues of this regimen. Combining two selected atypical drugs in a complementary way may minimize side-effects and enhance efficacy. In order to specify these advantages it is intend to examine approaches to combination treatment: Amisulpride and olanzapine show complementing receptor binding profiles and have shown to have efficacy and good tolerability when administered in combination in retrospective studies. The object of this trial is to study whether acutely ill patients with combination of amisulpride and olanzapine are more frequently in symptomatic remission after 8 weeks than those with olanzapine or amisulpride monotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with schizophrenia and schizoaffective disorder according to International Classification of Diseases (ICD-10);
- •age 18-65;
- •Positive and Negative Symptom Scale Total-Score ≥ 70 and two items of the positive symptom subscale ≥
- •voluntary treatment after written informed consent
- •legal capacity
- •exclusion of pregnancy by laboratory test (Beta HCG)
排除标准
- •participation in other interventional studies with drugs or medical devices
- •first episode patients
- •physical disease that might have effects on the conduct or evaluation of the trial
- •contraindications to medication according to experts information
- •oversensitivity to active substance or other component of the drugs used
- •known clozapine resistance
- •suicidal ideation
- •pregnancy or lactation
- •which of pregnancy or absence save contraception
- •dependency to sponsor or investigator
- •institutionalization through judicial or regulatory order
- •oversensitivity to placebo (mannite/aerosil)
研究组 & 干预措施
Olanzapine or Placebo
干预措施: Amisulpride (Drug)
Olanzapine or Placebo
干预措施: Olanzapine and Amisulpride (Drug)
Amisulpride or Placebo
干预措施: Olanzapine (Drug)
Amisulpride or Placebo
干预措施: Olanzapine and Amisulpride (Drug)
Olanzapine and Amisulpride
干预措施: Olanzapine (Drug)
Olanzapine and Amisulpride
干预措施: Amisulpride (Drug)
结局指标
主要结局
Symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS)
时间窗: 8 weeks
Whether there is a symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS)
次要结局
- Symptomatic improvement of schizophrenia after 16 weeks of treatment in comparison to time of inclusion of patient measured py PANSS total score reduction(16 weeks.)
- PANSS total score reduction from baseline to week 2 as a predictor of the change after 8 weeks(8 weeks)
- Serious adverse drug reactions(16 weeks)
- Symptomatic improvement of schizophrenia from baseline to week 2 up to week 16 measured by PANSS total score reduction.(Every 2 weeks up to week 16.)
- Change of clinical condition measured by Clinical Global Impression Scale (CGI scale)(every 2 weeks from baseline up to week 16)
- Change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale (SWN-K)(between week 0, 8, 16)