Efficacy and Safety of Aripiprazole 2.5mg Combine Sertraline 50mg in Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- score change of Hamilton Rating Scale For Depression (HAM-D17 )
研究概览
简要总结
FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant medications for refractory major depression. But there is still no trial about atypical antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients. This project aims to compare the efficacy and tolerability of sertraline with or without low-dosed aripiprazole added in fresh major depression.
详细描述
This double-blind, placebo-control, fixed dose, randomized study will be conducted at a tertiary clinical setting. Patients over 18 y/o fulfilled DSM-IV criteria for major depression, having a baseline HAM-D score ≧ 14 and a HAM-D item 3 score < 3 will be recruited into the groups. The study group of patients will receive ten weeks of treatment with a combination of fix-dosed sertraline and aripiprazole. The control group will received sertraline only. The score reduction in HAM-D17, CGI, SF-36 and Brief Symptom Rating Scale (BSRS-50) will be periodically estimated as an efficacy following the use of a SSRIs or and aripiprazole.
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
- •Male or female subjects 18 to 65 years inclusive.
- •Fulfilled DSM-Ⅳ criteria for major depressive disorder.
- •Onset ≧2 weeks.
- •Baseline score ≧14 on the HAM-D
- •Written informed consent prior to entry into the study.
排除标准
- •HAM-D17 item 3 score≧
- •Life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
- •Current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
- •Mood disorder due to general medical condition.
- •Treatment with antidepressants at entry into the study before 2 weeks.
- •Need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose.
- •Known intolerance or inefficacy to either drug.
- •Previous lack of response to two or more antidepressants at adequate dosage.
- •Subjects who have acute or unstable medical illness or organic failure.
- •Pregnancy and breast-feeding.
研究组 & 干预措施
aripiprazole and sertraline
The patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and aripiprazole 2.5mg/day.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50.
干预措施: aripiprazole , sertraline (Drug)
sertraline and placebo
The patients of this arm receive ten weeks of treatment with a combination of sertraline 50mg/day and placebo.The effect of this arm is assessed for HAM-D17, CGI, SF-36 and BSRS-50.
干预措施: aripiprazole , sertraline (Drug)
结局指标
主要结局
score change of Hamilton Rating Scale For Depression (HAM-D17 )
时间窗: day 1 / 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10weeks
次要结局
- score change of Brief Psychiatric Rating Scale (BPRS-50)(day 1/ 1 week / 2 weeks/ 4 weeks/ 6 weeks/ 10 weeks)