Keller M B, Kocsis J H, Thase M E, Gelenberg A J, Rush A J, Koran L, Schatzberg A, Russell J, Hirschfeld R, Klein D, McCullough J P, Fawcett J A, Kornstein S, LaVange L, Harrison W
Department of Psychiatry, Butler Hospital, Brown University, Providence, RI 02906, USA.
JAMA. 1998 Nov 18;280(19):1665-72. doi: 10.1001/jama.280.19.1665.
The chronic form of major depression is associated with a high rate of prevalence and disability, but no controlled research has examined the impact of long-term treatment on the course and burden of illness.
To determine if maintenance therapy with sertraline hydrochloride can effectively prevent recurrence of depression in the high-risk group of patients experiencing chronic major depression or major depression with antecedent dysthymic disorder ("double depression").
A 76-week randomized, double-blind, parallel-group study, conducted from September 1993 to November 1996.
Outpatient psychiatric clinics at 10 academic medical centers and 2 clinical research centers.
Maintenance treatment with either sertraline hydrochloride (n = 77) in flexible doses up to 200 mg or placebo (n = 84).
A total of 161 outpatients with chronic major or double depression who responded to sertraline in a 12-week, double-blind, acute-phase treatment trial and continued to have a satisfactory therapeutic response during a subsequent 4-month continuation phase.
Time to recurrence of major depression.
Sertraline afforded significantly greater prophylaxis against recurrence than did placebo (5 [6%] of 77 in the sertraline group vs 19 [23%] of 84 in the placebo group; P = .002 for the log-rank test of time-to-recurrence distributions). Clinically significant depressive symptoms reemerged in 20 (26%) of 77 patients treated with sertraline vs 42 (50%) of 84 patients who received placebo (P = .001). With use of a Cox proportional hazards model, patients receiving placebo were 4.07 times more likely (95% CI, 1.51-10.95; P = .005) to experience a depression recurrence, after adjustment for study site, type of depression, and randomization strata.
Maintenance therapy with sertraline is well tolerated and has significant efficacy in preventing recurrence or reemergence of depression in chronically depressed patients.
重度抑郁症的慢性形式与高患病率和残疾率相关，但尚无对照研究考察长期治疗对疾病进程和负担的影响。
确定盐酸舍曲林维持治疗能否有效预防慢性重度抑郁症或伴有先前心境恶劣障碍（“双重抑郁症”）的重度抑郁症高危患者群体的抑郁症复发。
一项为期76周的随机、双盲、平行组研究，于1993年9月至1996年11月进行。
10家学术医疗中心的门诊精神科诊所和2个临床研究中心。
采用灵活剂量高达200mg的盐酸舍曲林（n = 77）或安慰剂（n = 84）进行维持治疗。
共有161例慢性重度或双重抑郁症门诊患者，他们在一项为期12周的双盲急性期治疗试验中对舍曲林有反应，并在随后4个月的延续期内持续有满意的治疗反应。
重度抑郁症复发时间。
与安慰剂相比，舍曲林预防复发的效果显著更好（舍曲林组77例中有5例[6%]复发，而安慰剂组84例中有19例[23%]复发；复发时间分布对数秩检验P = 0.002）。接受舍曲林治疗的77例患者中有20例（26%）出现具有临床意义的抑郁症状复发，而接受安慰剂治疗的84例患者中有42例（50%）出现复发（P = 0.001）。使用Cox比例风险模型，在对研究地点、抑郁症类型和随机分组层次进行调整后，接受安慰剂治疗的患者抑郁症复发的可能性高4.07倍（95%CI，1.51 - 10.95；P = 0.005）。
盐酸舍曲林维持治疗耐受性良好，在预防慢性抑郁症患者抑郁症复发或再发方面具有显著疗效。
