Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- social function
研究概览
简要总结
The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.
详细描述
The aim of this study is to evaluate the therapeutic effect of escitalopram (cipralex) in the treatment of negative symptoms in schizophrenic patients receiving either typical or the newer atypical antipsychotics (olanzapine and risperidone) in a double-blind placebo-controlled study. As there is no drug treatment that is considered as first-line treatment in the treatment of negative symptoms, we thought that the comparison with placebo is plausible. However, it is important to note that the patients will receive the commonly used treatment for their disorder (i.e. antipsychotic medication).
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
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic schizophrenia patients,
- •Age <60,
- •Medicated,
- •Inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
- •Patients will be clinically stable and free of any additional axis I diagnosis or significant medical illnesses before enrollment into the study.
- •A Positive and Negative Syndrome Scale (PANSS) score of 50 or above will be required for entry to the study.
排除标准
- •Comorbidity with mania or major depression,
- •Pregnancy,
- •Lactation,
- •Impaired renal or hepatic function,
- •History of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (SSRI) group.
- •Additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and CGI scores of "condition much worsened".
- •Patients will be excluded during the study if they will remove their informed consent.
结局指标
主要结局
social function
negative symptoms
次要结局
- positive symptoms
- Clinical Global Impression (CGI)
- depression