Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada2Mood Disorders Centre, Djavad Mowafaghian Centre for Brain Health, Vancouver, British Columbia, Canada.
Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada4Mood Disorders Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.
Bright light therapy is an evidence-based treatment for seasonal depression, but there is limited evidence for its efficacy in nonseasonal major depressive disorder (MDD).
To determine the efficacy of light treatment, in monotherapy and in combination with fluoxetine hydrochloride, compared with a sham-placebo condition in adults with nonseasonal MDD.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo- and sham-controlled, 8-week trial in adults (aged 19-60 years) with MDD of at least moderate severity in outpatient psychiatry clinics in academic medical centers. Data were collected from October 7, 2009, to March 11, 2014. Analysis was based on modified intent to treat (randomized patients with ≥1 follow-up rating).
Patients were randomly assigned to (1) light monotherapy (active 10,000-lux fluorescent white light box for 30 min/d in the early morning plus placebo pill); (2) antidepressant monotherapy (inactive negative ion generator for 30 min/d plus fluoxetine hydrochloride, 20 mg/d); (3) combination light and antidepressant; or (4) placebo (inactive negative ion generator plus placebo pill).
Change score on the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to the 8-week end point. Secondary outcomes included response (≥50% reduction in MADRS score) and remission (MADRS score ≤10 at end point).
A total of 122 patients were randomized (light monotherapy, 32; fluoxetine monotherapy, 31; combination therapy, 29; placebo, 30). The mean (SD) changes in MADRS score for the light, fluoxetine, combination, and placebo groups were 13.4 (7.5), 8.8 (9.9), 16.9 (9.2), and 6.5 (9.6), respectively. The combination (effect size [d] = 1.11; 95% CI, 0.54 to 1.64) and light monotherapy (d = 0.80; 95% CI, 0.28 to 1.31) were significantly superior to placebo in the MADRS change score, but fluoxetine monotherapy (d = 0.24; 95% CI, -0.27 to 0.74) was not superior to placebo. For the respective placebo, fluoxetine, light, and combination groups at the end point, response was achieved by 10 (33.3%), 9 (29.0%), 16 (50.0%), and 22 (75.9%) and remission was achieved by 9 (30.0%), 6 (19.4%), 14 (43.8%), and 17 (58.6%). Combination therapy was superior to placebo in MADRS response (β = 1.70; df = 1; P = .005) and remission (β = 1.33; df = 1; P = .02), with numbers needed to treat of 2.4 (95% CI, 1.6 to 5.8) and 3.5 (95% CI, 2.0 to 29.9), respectively. All treatments were generally well tolerated, with few significant differences in treatment-emergent adverse events.
Bright light treatment, both as monotherapy and in combination with fluoxetine, was efficacious and well tolerated in the treatment of adults with nonseasonal MDD. The combination treatment had the most consistent effects.
clinicaltrials.gov Identifier: NCT00958204.
光疗法是一种治疗季节性抑郁症的循证疗法，但在非季节性重性抑郁症（MDD）中，其疗效的证据有限。
确定光治疗在非季节性 MDD 成人中作为单药治疗以及与氟西汀盐酸盐联合治疗的疗效，与假对照条件相比。
设计、地点和参与者： 在学术医疗中心的门诊精神病诊所，对至少有中度严重程度的 MDD 的成年患者进行了为期 8 周的随机、双盲、安慰剂和假对照试验。数据于 2009 年 10 月 7 日至 2014 年 3 月 11 日收集。分析基于改良意向治疗（随机患者有≥1 次随访评分）。
患者被随机分配到（1）光单药治疗（清晨进行 30 分钟/d 的 10000 勒克斯荧光白光灯治疗，同时服用安慰剂丸）；（2）抗抑郁药单药治疗（30 分钟/d 的无效负离子发生器加氟西汀盐酸盐，20 毫克/d）；（3）联合光和抗抑郁药；或（4）安慰剂（无效负离子发生器加安慰剂丸）。
从基线到 8 周终点的蒙哥马利-阿斯伯格抑郁评定量表（MADRS）的变化分数。次要结果包括反应（MADRS 评分降低≥50%）和缓解（MADRS 评分≤10 分）。
共有 122 名患者被随机分配（光单药治疗组 32 例，氟西汀单药治疗组 31 例，联合治疗组 29 例，安慰剂组 30 例）。光、氟西汀、联合和安慰剂组的 MADRS 评分变化的平均（SD）分别为 13.4（7.5）、8.8（9.9）、16.9（9.2）和 6.5（9.6）。联合（效应大小[d] = 1.11；95%置信区间，0.54 至 1.64）和光单药治疗（d = 0.80；95%置信区间，0.28 至 1.31）在 MADRS 评分变化方面明显优于安慰剂，但氟西汀单药治疗（d = 0.24；95%置信区间，-0.27 至 0.74）与安慰剂相比并不优越。在终点时，各自的安慰剂、氟西汀、光和联合组中，10 例（33.3%）、9 例（29.0%）、16 例（50.0%）和 22 例（75.9%）实现了反应，9 例（30.0%）、6 例（19.4%）、14 例（43.8%）和 17 例（58.6%）实现了缓解。联合治疗在 MADRS 反应（β=1.70；df=1；P=0.005）和缓解（β=1.33；df=1；P=0.02）方面优于安慰剂，治疗出现不良事件的人数分别为 2.4（95%置信区间，1.6 至 5.8）和 3.5（95%置信区间，2.0 至 29.9）。所有治疗均能较好耐受，治疗出现不良事件的差异较小。
光治疗，无论是单药治疗还是与氟西汀盐酸盐联合治疗，在治疗非季节性 MDD 成人中均有效且耐受良好。联合治疗的效果最为一致。
clinicaltrials.gov 标识符：NCT00958204。
