Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D)
研究概览
简要总结
Relatively drug naive patients will receive two antidepressant medications as initial treatment.
详细描述
While antidepressant medications are often effective in relieving depressive symptoms, at least 60% of patients do not remit with the first agent tried. This pilot study will assess whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is both tolerated and improves response while decreasing drop outs. This is a replication of a previous study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
- •HAMD-D (21-Item) > 9
排除标准
- •Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d)
- •History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia)
- •History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable
- •Alcohol and/or drug abuse/dependence during past year
- •Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
- •Bipolar I, Bipolar II
- •History of Psychosis, or current Psychosis
- •Currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for Anxiety is allowed)
- •Not currently depressed (whether considered due to current treatment or not)
- •Active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
- •Pregnant or breast-feeding
- •Premenopausal women not using known effective birth control
研究组 & 干预措施
escitalopram + bupropion
patients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d
干预措施: escitalopram + bupropion (Drug)
结局指标
主要结局
Hamilton Depression Scale (HAM-D)
时间窗: 10 weeks
次要结局
- Beck Depression Inventory (BDI)(10 weeks)
- Clinical Global Impression Scale (CGI)(10 weeks)
- Patient Global Impression Scale (PGI)(10 weeks)
- Arizona Sexual Experience Scale (ASEX)(10 weeks)