Wexham Park Hospital, UK.
Psychiatr Danub. 2010 Nov;22 Suppl 1:S49-52.
clinicians have long noticed a correlation between physiological markers of inflammation and depression. The best-known example is the activation of the hypothalamus-pituitary-adrenal axis and cortisol secretion; however more recent studies have demonstrated increased salivary prostaglandins and plasma acute phase proteins in depressed patients. To date four randomised controlled trials have used celecoxib or rofecoxib as adjuncts to serotonin selective reuptake inhibitors in the treatment of depression. These suggested a statistically significant decrease in depressive symptoms in the patients taking NSAIDs and SSRIs, compared to patients taking SSRIs alone. Interpretation of these results is limited by the small sample size and short duration of these preliminary studies. The research only considers depressed patients receiving treatment in secondary care; no study has examined the effectiveness of NSAIDs as an adjunct in primary care, even though most cases of depression in the UK are managed in the community by general practitioners.
we propose a multi-centre double-blinded randomised controlled trial with two objectives: to determine whether citalopram plus celecoxib dual therapy achieves a greater reduction in depressive symptoms (quantified using the Hamilton Depression Rating Scale (HDRS)) within four weeks, compared to citalopram monotherapy; and to determine whether citalopram plus celecoxib dual therapy is more likely to achieve remission (HDRS score ?7) of moderate to severe depression within six months, compared with citalopram monotherapy. The endpoints will be the reduction in HDRS score after 4 weeks of treatment, and the HDRS score after 26 weeks of treatment. The study will enrol 452 participants from general practices who have a moderate or severe, current or recurrent major depressive episode when medication with an SSRI is considered. The study population will be stratified according to age, sex, HDRS score, age of onset of first episode, number of previous depressive episodes and duration of current episode. The population will then be randomised into two groups. Subjects will be interviewed to determine HDRS score, measure blood pressure, count pills and discuss side-effects. This will occur weekly for the first four weeks, and every four weeks thereafter.
临床医生早就注意到炎症的生理标志物与抑郁症之间存在关联。最著名的例子是下丘脑-垂体-肾上腺轴的激活和皮质醇的分泌；然而，最近的研究表明，抑郁患者的唾液前列腺素和血浆急性期蛋白增加。迄今为止，已有四项随机对照试验使用塞来昔布或罗非昔布作为辅助药物，与选择性 5-羟色胺再摄取抑制剂联合治疗抑郁症。这些研究表明，与单独使用 SSRIs 的患者相比，服用 NSAIDs 和 SSRIs 的患者的抑郁症状有统计学上的显著下降。但这些结果的解释受到这些初步研究样本量小和持续时间短的限制。该研究仅考虑在二级护理中接受治疗的抑郁患者；没有研究检查 NSAIDs 作为辅助药物在初级保健中的有效性，尽管英国大多数抑郁症病例都是由全科医生在社区管理的。
我们提出了一项多中心双盲随机对照试验，有两个目标：确定与单独使用西酞普兰相比，西酞普兰加塞来昔布联合治疗是否能在四周内更显著地减轻抑郁症状（用汉密尔顿抑郁量表（HDRS）量化）；并确定与单独使用西酞普兰相比，西酞普兰加塞来昔布联合治疗是否更有可能在六个月内缓解中度至重度抑郁症（HDRS 评分？7）。终点将是治疗 4 周后 HDRS 评分的降低，以及治疗 26 周后 HDRS 评分的降低。该研究将从有中度或重度、当前或复发性重度抑郁症发作的患者中招募 452 名来自普通诊所的参与者，当考虑使用 SSRIs 药物治疗时。研究人群将根据年龄、性别、HDRS 评分、首次发作年龄、既往抑郁发作次数和当前发作持续时间进行分层。然后，人群将被随机分为两组。将对受试者进行访谈以确定 HDRS 评分、测量血压、计数药丸并讨论副作用。前四周每周进行一次，之后每四周进行一次。
