Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in Depression Severity (measured by HAMD-17)
研究概览
简要总结
The study aims to compare the antidepressant effects of a dextromethorphan-bupropion combination versus standard SSRI therapy in adult patients with major depressive disorder. Participants will be randomized into two groups: one receiving dextromethorphan-bupropion and the other receiving an SSRI (e.g., sertraline or escitalopram). Treatment will last for 6 weeks, with assessments at baseline and study completion. The primary outcome will be the remission rate measured by a validated depression rating scale. Secondary outcomes include change in depressive symptoms severity and safety/tolerability measures.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Diagnosed with major depressive disorder (MDD) per DSM-5 criteria.
- •Baseline depression score indicating moderate to severe depression
- •Ability to provide informed consent
- •Willing to comply with study requirements
排除标准
- •History of bipolar disorder, schizophrenia, or other psychotic disorders
- •Current substance use disorder (within past 6 months)
- •Active suicidal ideation requiring urgent intervention
- •Pregnancy or breastfeeding
- •Known hypersensitivity to study medications
研究组 & 干预措施
SSRI Group
Participants will receive an SSRI at standard therapeutic doses, administered orally for 6 weeks.
干预措施: SSRIs (Drug)
Dextromethorphan-Bupropion Group
Participants will receive a fixed-dose combination of dextromethorphan-bupropion, dosed according to approved guidelines for major depressive disorder, administered orally for 6 weeks.
干预措施: Dextromethorphan-Bupropion (Drug)
结局指标
主要结局
Change in Depression Severity (measured by HAMD-17)
时间窗: 6 weeks
Change from baseline in depressive symptom scores, measured using the Hamilton Depression Rating Scale, 17-item version (HAMD-17; score range 0-52, with higher scores indicating worse depression severity).
次要结局
- Remission Rate(6 weeks)
研究者
Asad Ullah Jan
Head Department of Psychiatry
Combined Military Hospital Nowshera