VA Connecticut Healthcare System, 950 Campbell Ave, Mailstop (182), West Haven, CT 06516.
VA New England Mental Illness, Research, Education and Clinical Center, West Haven, Connecticut, USA.
J Clin Psychiatry. 2020 Jun 23;81(4):19m13038. doi: 10.4088/JCP.19m13038.
To determine whether concurrent posttraumatic stress disorder (PTSD) should affect whether to augment or switch medications when major depressive disorder (MDD) has not responded to a prior antidepressant trial.
Patients at 35 Veterans Health Administration medical centers from December 2012 to May 2015 with nonpsychotic MDD (N = 1,522) and a suboptimal response to adequate antidepressant treatment were randomly assigned to 3 "next step" treatments: switching to bupropion, augmenting the current antidepressant with bupropion, and augmenting with the antipsychotic aripiprazole. Blinded ratings with the 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C₁₆) determined remission and response by 12 weeks and relapse after remission. Survival analyses compared treatment effects in patients with concurrent PTSD diagnosed with the Mini-International Neuropsychiatric Interview (n = 717, 47.1%) and those without PTSD (n = 805, 52.9%).
Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks. Augmentation with aripiprazole was associated with greater likelihood of achieving response (68.4%) than switching to bupropion (57.7%) in patients with PTSD (relative risk [RR] = 1.26; 95% CI, 1.01-1.59) as well as in patients without PTSD (RR = 1.29; 95% CI, 1.05-1.97) (78.9% response with aripiprazole augmentation vs 66.9% with switching to bupropion). Treatment comparisons with the group receiving augmentation with bupropion were not significant. There was no significant interaction between treatment group and PTSD on remission (P = .70), response (P = .98), or relapse (P = .15).
Although PTSD was associated with poorer overall outcomes, the presence of concurrent PTSD among Veterans in this trial did not affect the comparative effectiveness of medications on response, remission, or relapse after initial remission.
ClinicalTrials.gov identifier: NCT01421342.
确定创伤后应激障碍（PTSD）是否会影响是否在先前的抗抑郁药试验未反应的情况下增加或更换药物，以治疗重度抑郁症（MDD）。
2012 年 12 月至 2015 年 5 月，35 个退伍军人健康管理中心的非精神病性 MDD（N=1522）患者和对充分的抗抑郁治疗反应不佳的患者被随机分配到 3 种“下一步”治疗方案中：换用安非他酮、用安非他酮增强当前的抗抑郁药，以及用抗精神病药阿立哌唑增强。16 项抑郁症状快速清单评定（QIDS-C₁₆）的盲法评定在 12 周时确定缓解和反应，以及缓解后的复发。生存分析比较了患有或不患有经 Mini-国际神经精神访谈（MINI）诊断的 PTSD（n=717，47.1%）患者的治疗效果。
患有 PTSD 的患者在基线时表现出更严重的抑郁症状，并且在 12 周时更不可能达到缓解或反应。在 PTSD 患者中，与换用安非他酮（57.7%）相比，阿立哌唑增强治疗更有可能达到反应（68.4%）（相对风险[RR]，1.26；95%置信区间，1.01-1.59），以及无 PTSD 的患者（RR=1.29；95%置信区间，1.05-1.97）（阿立哌唑增强治疗的反应率为 78.9%，换用安非他酮的反应率为 66.9%）。与接受安非他酮增强治疗的组相比，治疗比较没有显著差异。在缓解（P=0.70）、反应（P=0.98）或复发（P=0.15）方面，治疗组与 PTSD 之间没有显著的相互作用。
尽管 PTSD 与总体结局较差有关，但在这项试验中，退伍军人中同时存在 PTSD 并没有影响药物对反应、缓解或缓解后复发的相对有效性。
ClinicalTrials.gov 标识符：NCT01421342。
