S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale Remission Rates
研究概览
简要总结
This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.
详细描述
Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in enhancing the effects of SSRIs in patients currently not responding to SSRI treatment.
This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks. Depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive disorder
- •Use of an SSRI for at least 6 weeks prior to study entry with partial or no response
排除标准
- •History of psychosis
- •Allergy to SAMe
- •Alcohol or drug abuse in the past 3 months prior to study entry
研究组 & 干预措施
1 Oral SAMe Tosylate
Participants receiving the oral SAMe tosylate
干预措施: S-adenosyl methione (SAMe) (Drug)
2 Oral Placebo Pill Twice Daily
Participants receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale Remission Rates
时间窗: Measured at Week 6
The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .
次要结局
- HDRS17 Responders(Measured at Week 6)
研究者
George I. Papakostas
Principal Investigator
Massachusetts General Hospital