Salicylic Augmentation in Depression
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Scale Score
研究概览
简要总结
The investigators are doing this research study to find out if using aspirin along with antidepressant treatment can lessen symptoms of depression. This study also aims to find out if some people improve more from taking aspirin than others. The investigators also want to see if it is possible to predict which participants will do better based on a blood test.
Aspirin is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter pain medication. But, aspirin is not approved by the FDA to make antidepressant treatment better.
This research study will compare aspirin to placebo.
详细描述
This study is a randomized, double-blind, placebo-control trial. The primary aims of this study are:
Aim 1: To evaluate the clinical effect of aspirin augmentation on depression.
Aim 2: To assess the inflammatory profile of the blood of the aspirin augmentation responders compared with the non-responders.
Aim 3: To evaluate whether immune gene expression patterns are associated with antidepressant response to aspirin.
Aim 4: To collect samples for later, more detailed immunologic characterization.
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)
盲法说明
Study team will be blinded to participant condition. Pharmacy will be responsible for providing study drug versus identical placebo to participants.
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
- •Current diagnosis of major depressive disorder
- •Hamilton Depression Rating Scale (HDRS) score of >19
- •Stable treatment regimen (no medication changes or changes in psychotherapy treatment in past 8 weeks, and no participation in stepped treatments, such as completion of a course of cognitive behavioral therapy, during the trial)
- •Failed to remit with at least 1 antidepressant trial, or combination of 1 antidepressant and 1 augmentation agent
- •Women of childbearing age must agree to use an approved method of contraception for the duration of the study
排除标准
- •Active suicidal ideation
- •History of manic episodes or psychosis
- •Alcohol or substance use disorder up to one month prior to first testing session
- •Comorbid neurologic condition affecting the central nervous system
- •Comorbid autoimmune condition
- •Uncorrected thyroid disease or a current abnormal thyroid-stimulating hormone (TSH)
- •Active or recent (within the past month) infection (such as otitis, pneumonia, urinary tract infection); temperature > 100.3 or white blood cell (WBC) count > 11 K/microL will be considered evidence of active infection even in the absence of other symptoms
- •History of GI bleed
- •History of stroke
- •History of a bleeding disorder
- •Platelet count < 150,000/mm3 on initial screening
- •On a blood-thinning agent or taking NSAIDs daily
- •Current use of oral steroids or other immunomodulating medications
- •Salicylate sensitivity
- •Pregnancy or breastfeeding
研究组 & 干预措施
Aspirin augmentation to treatment
Participants who meet inclusion criteria for the study and are randomized to the active treatment arm will be given pills for the ensuing 8 weeks, consisting of a daily dose of aspirin 325 mg to be taken every evening before bed.
干预措施: Aspirin 325mg (Drug)
Placebo augmentation to treatment
Participants randomized to the placebo arm will receive a placebo oral tablet of the same size, shape, and color as the aspirin tablet. Participants will be instructed to take their pills in the evening before bed.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in Hamilton Depression Scale Score
时间窗: 8 weeks
Change in HDRS score in the treatment versus control groups.
次要结局
- Response of Inflammatory Biomarkers(2 years)
- Biomarker Association With Antidepressant Response(2 years)
研究者
Jessica Harder
Principle Investigator
Brigham and Women's Hospital