Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The principal measure of the outcome will be the 17-item Ham-D
研究概览
简要总结
Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients
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
- •Patients with age greater than 18 years old.
- •Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.
排除标准
- •Patients with bipolar I or bipolar II disorder; eating disorders, personality disorders, and mental retardation, current diagnosis anxiety disorders (except for specific phobia), mental disorder due to general medical condition; met criteria for substance dependence or abuse in the previous three months; have a concurrent medical illness or history of seizures that would contraindicate use of the study medication and are receiving Electroconvulsive therapy (ECT).
- •Pregnant women or women not using medically accepted means of birth control are excluded.
- •Persons who score greater than 2 on the suicide item of the Ham-D, or who are judged to have significant suicidal ideation or potential in the view of an investigator, are excluded.
- •Patients who are required to be free of all psychotropic except for escitalopram and anti-inflammatory medications for at least four weeks before study entry.
研究组 & 干预措施
Comparative group
35 patients will receive fluoxetine 20 mg/day plus roflumilast
干预措施: Roflumilast (Drug)
Control group
30 patients will receive fluoxetine 20 mg/day plus placebo
干预措施: Placebo (Drug)
Comparative group
35 patients will receive fluoxetine 20 mg/day plus roflumilast
干预措施: Fluoxetine (Drug)
Control group
30 patients will receive fluoxetine 20 mg/day plus placebo
干预措施: Fluoxetine (Drug)
结局指标
主要结局
The principal measure of the outcome will be the 17-item Ham-D
时间窗: 2 months
2\. Patients will be assessed by a psychiatrist at baseline, 4, and 8 weeks after starting the medication. The principal measure of the outcome will be the 17-item Ham-D.
次要结局
未报告次要终点