Double-blind Clinical Trial Controlled With Placebo of the Efficacy of Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 4 期
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
研究概览
简要总结
Main objective: To assess the efficacy of two antidepressants of different pharmacological families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of schizophrenia.
Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct treatments to risperidone and olanzapine for the treatment of cognitive symptoms of schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for the treatment of negative and cognitive symptoms of schizophrenia.
Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria) and significant negative symptoms, will be recruited in the 9 participating centres. Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP, Hamilton scale, BACS)
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 (Participant, Investigator)
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
- •Diagnosis of schizophrenia (DSM-IV criteria)
- •Stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
- •Presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the PANSS scale) (Kay 1987)
- •Patients have to give written informed consent to participate in the study
排除标准
- •Patients with a substance abuse/dependence diagnosis in the previous six months.
- •Mental Retardation.
- •Patients taking antidepressant in the last 4 months before the trial.
- •Patients taking other antipsychotic medication, except: sinquan 100, Entumine 40, Largactil 100 and Seroquel
- •Patients who score more than 20 in Hamilton Rating Scale for Depression.
- •Pregnancy or lactation.
- •Serious impaired kidney function.
- •History of hemorrhagic disorders.
- •Reboxetine or citalopram allergy.
研究组 & 干预措施
sugar pill
干预措施: Reboxetine (Drug)
sugar pill
干预措施: citalopram (SSRI) (Drug)
reboxetine (NRI)
干预措施: citalopram (SSRI) (Drug)
citalopram (SSRI)
干预措施: Reboxetine (Drug)
结局指标
主要结局
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
时间窗: 24 weeks
次要结局
- Secondary efficacy endpoints will be the change in the scores of the total PANSS and all the other clinical, social and neuropsychological scales from baseline to follow-up evaluation.(24 weeks)