背景:免疫失调可以在抑郁症的病理生理学中发挥作用,研究表明,免疫拮抗剂可以改善难治性双相抑郁(TRD)患者的抑郁症状。
目的:评价抗炎药的抗抑郁作用,己酮可可碱(PTX)在TRD双相I/II成人受试者中的应用。
方法:这12周,随机化,双盲,安慰剂对照,在埃尔比勒的霍勒精神病医院和私人诊所进行了60名参与者的平行组试验,伊拉克。根据DSM-5标准,参与者被确认为符合双相I/II抑郁的资格。使用改良的意向治疗分析对数据进行分析。
结果:两组在汉密尔顿抑郁量表(HAM-D-17)评分(χ2=1.9,P=0.48)或显著时间×治疗交互作用(χ2=7.1,P=0.54)方面无显著差异。然而,两组HAM-D-17评分从开始到终点均有显著的时间效应(χ2=2.11,P=0.002).此外,发现显著的时间×治疗×CRP交互作用(χ2=3.1,P=0.016),在CRP>7.1mg/L的PTX治疗的受试者中,HAM-D-17评分降低更多。PTX和安慰剂组之间的反应率差异未达到显着水平(χ2=0.84,p=0.43)。此外,血清TNF-α浓度,CRP,在PTX组中,IL-6和IL-6在第12周显著降低(分别为P=.007、.04和<.001)。
结论:目前的概念验证研究发现,就双相情感障碍患者的整体抗抑郁效果而言,PTX并不优于安慰剂。然而,它可以改善治疗前炎症水平较高的受试者亚群的抑郁情绪.
背景:NCT05324735。
BACKGROUND: Immune dysregulation can play a role in depression pathophysiology, and immunological antagonists can improve depressive symptoms in treatment-resistant bipolar depression (TRD) patients according to studies.
OBJECTIVE: To evaluate the anti-depressant effects of the anti-inflammatory drug, pentoxifylline (PTX) in TRD bipolar I/II adult subjects.
METHODS: This 12-week, randomized, double-blind, placebo-controlled, parallel-group
trial of 60 participants was conducted at Hawler Psychiatric Hospital and Private Clinic in Erbil, Iraq. Participants were confirmed as being qualified for bipolar I/II depression based on DSM-5 criteria. Data were analyzed using modified intent-to-treat analysis.
RESULTS: There were no significant differences between the two groups in Hamilton Rating Scale for Depression-17 (HAM-D-17) scores (χ2=1.9, P =.48) or a significant time × treatment interaction (χ2=7.1, P=.54). Nevertheless, a significant effect of time was observed with both groups\' reduction in HAM-D-17 scores from the start to the endpoint (χ2= 2.11, P=.002). Besides, a significant time × treatment × CRP interaction was found (χ2=3.1, P=0.016), where there was more reduction in HAM-D-17 score in PTX-treated subjects with CRP> 7.1 mg/L. The response rate difference between PTX and the placebo group did not reach a significance level (χ2=0.84, p=0.43). Furthermore, serum concentrations of TNF-α, CRP, and IL-6 significantly reduced at week 12 in the PTX group (P=.007,.04, and <.001, respectively).
CONCLUSIONS: The current proof of concept
study found that in terms of overall anti-depressant effectiveness in bipolar patients with TRD, PTX is not superior to placebo. However, it may improve depressive mood in a subpopulation of subjects with a higher pretreatment inflammatory profile.