Tollefson G D, Sayler M E
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA.
Depress Anxiety. 1996;4(6):294-311. doi: 10.1002/(SICI)1520-6394(1996)4:6<294::AID-DA6>3.0.CO;2-C.
Psychomotor agitation, a common clinical feature of major depression, may first emerge or intensify during pharmacotherapy. Whether agitation is part of the underlying course of depression or iatrogenic complicates treatment planning. We analyzed data from blinded clinical trials involving 4,737 patients with major depression assigned to a selective serotonin reuptake inhibitor (fluoxetine), a comparator antidepressant (usually a tricyclic antidepressant [TCA]), or placebo. Item 9 of the Hamilton Depression Rating Scale was used to assess the degree of psychomotor agitation. The vast majority of depressed patients exhibited baseline psychomotor agitation. The rate of increased agitation from baseline during acute pharmacotherapy was comparable between fluoxetine and either placebo or TCAs. Substantial emergence of psychomotor agitation also occurred at a similar incidence across the three treatment groups and typically appeared within the first 3 wk. Improvement in agitation was significantly more prominent (P < 0.001) among fluoxetine-treated than among placebo-treated patients. Fluoxetine-treated patients demonstrated numerically superior improvement rates compared with TCA-treated patients; however, this difference was not significant. Data derived from this large series of clinical trials suggested no evidence that either fluoxetine or TCAs induced psychomotor agitation at rates exceeding the natural course of the disorder over time (placebo cohort). On the contrary, pharmacotherapy with either fluoxetine or TCAs was typically associated with diminished agitation, probably as part of the response pattern of depression.
精神运动性激越作为重度抑郁症的常见临床特征，可能在药物治疗期间首次出现或加重。激越是抑郁症潜在病程的一部分还是医源性因素导致的，这使得治疗方案的制定变得复杂。我们分析了来自双盲临床试验的数据，这些试验涉及4737例重度抑郁症患者，他们被分配接受选择性5-羟色胺再摄取抑制剂（氟西汀）、对照抗抑郁药（通常为三环类抗抑郁药[TCA]）或安慰剂治疗。使用汉密尔顿抑郁量表第9项来评估精神运动性激越的程度。绝大多数抑郁症患者表现出基线精神运动性激越。在急性药物治疗期间，氟西汀组与安慰剂组或TCA组相比，激越程度从基线增加的发生率相当。三个治疗组中精神运动性激越的显著出现发生率相似，且通常在最初3周内出现。与接受安慰剂治疗的患者相比，接受氟西汀治疗的患者激越症状的改善明显更显著（P<0.001）。与接受TCA治疗的患者相比，接受氟西汀治疗的患者在数字上显示出更高的改善率；然而，这种差异并不显著。从这一系列大型临床试验中获得的数据表明，没有证据显示氟西汀或TCA导致精神运动性激越的发生率超过该疾病随时间的自然病程（安慰剂组）。相反，氟西汀或TCA药物治疗通常与激越症状减轻相关，这可能是抑郁症反应模式的一部分。
