Brent David, Emslie Graham, Clarke Greg, Wagner Karen Dineen, Asarnow Joan Rosenbaum, Keller Marty, Vitiello Benedetto, Ritz Louise, Iyengar Satish, Abebe Kaleab, Birmaher Boris, Ryan Neal, Kennard Betsy, Hughes Carroll, DeBar Lynn, McCracken James, Strober Michael, Suddath Robert, Spirito Anthony, Leonard Henrietta, Melhem Nadine, Porta Giovanna, Onorato Matthew, Zelazny Jamie
JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
Only about 60% of adolescents with depression will show an adequate clinical response to an initial treatment trial with a selective serotonin reuptake inhibitor (SSRI). There are no data to guide clinicians on subsequent treatment strategy.
To evaluate the relative efficacy of 4 treatment strategies in adolescents who continued to have depression despite adequate initial treatment with an SSRI.
DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of a clinical sample of 334 patients aged 12 to 18 years with a primary diagnosis of major depressive disorder that had not responded to a 2-month initial treatment with an SSRI, conducted at 6 US academic and community clinics from 2000-2006.
Twelve weeks of: (1) switch to a second, different SSRI (paroxetine, citalopram, or fluoxetine, 20-40 mg); (2) switch to a different SSRI plus cognitive behavioral therapy; (3) switch to venlafaxine (150-225 mg); or (4) switch to venlafaxine plus cognitive behavioral therapy.
Clinical Global Impressions-Improvement score of 2 or less (much or very much improved) and a decrease of at least 50% in the Children's Depression Rating Scale-Revised (CDRS-R); and change in CDRS-R over time.
Cognitive behavioral therapy plus a switch to either medication regimen showed a higher response rate (54.8%; 95% confidence interval [CI], 47%-62%) than a medication switch alone (40.5%; 95% CI, 33%-48%; P = .009), but there was no difference in response rate between venlafaxine and a second SSRI (48.2%; 95% CI, 41%-56% vs 47.0%; 95% CI, 40%-55%; P = .83). There were no differential treatment effects on change in the CDRS-R, self-rated depressive symptoms, suicidal ideation, or on the rate of harm-related or any other adverse events. There was a greater increase in diastolic blood pressure and pulse and more frequent occurrence of skin problems during venlafaxine than SSRI treatment.
For adolescents with depression not responding to an adequate initial treatment with an SSRI, the combination of cognitive behavioral therapy and a switch to another antidepressant resulted in a higher rate of clinical response than did a medication switch alone. However, a switch to another SSRI was just as efficacious as a switch to venlafaxine and resulted in fewer adverse effects.
clinicaltrials.gov Identifier: NCT00018902.
在患有抑郁症的青少年中，只有约60%的人在首次使用选择性5-羟色胺再摄取抑制剂（SSRI）进行治疗试验时会表现出足够的临床反应。目前尚无数据指导临床医生制定后续治疗策略。
评估4种治疗策略对那些尽管初始使用SSRI进行了充分治疗但仍持续患有抑郁症的青少年的相对疗效。
设计、地点和参与者：对334例年龄在12至18岁、初步诊断为重度抑郁症且对SSRI进行2个月初始治疗无反应的临床样本进行随机对照试验，该试验于2000年至2006年在美国的6家学术和社区诊所开展。
为期12周的：（1）换用第二种不同的SSRI（帕罗西汀、西酞普兰或氟西汀，20 - 40毫克）；（2）换用不同的SSRI加认知行为疗法；（3）换用文拉法辛（150 - 225毫克）；或（4）换用文拉法辛加认知行为疗法。
临床总体印象改善评分达到2或更低（显著改善或非常显著改善），且儿童抑郁评定量表修订版（CDRS - R）降低至少50%；以及CDRS - R随时间的变化。
认知行为疗法加换用任一药物治疗方案的反应率（54.8%；95%置信区间[CI]，47% - 62%）高于单纯换用药物（40.5%；95% CI，33% - 48%；P = 0.009），但文拉法辛和第二种SSRI之间的反应率无差异（48.2%；95% CI，41% - 56%对47.0%；95% CI，40% - 55%；P = 0.83）。在CDRS - R变化、自评抑郁症状、自杀意念或伤害相关或任何其他不良事件发生率方面，各治疗组间无差异。与SSRI治疗相比，文拉法辛治疗期间舒张压和脉搏升高更明显，皮肤问题出现更频繁。
对于对SSRI初始充分治疗无反应的青少年抑郁症患者，认知行为疗法与换用另一种抗抑郁药联合使用的临床反应率高于单纯换用药物。然而，换用另一种SSRI与换用文拉法辛疗效相当，且不良反应更少。
clinicaltrials.gov标识符：NCT00018902。
