Division of Services and Intervention Research, National Institute of Mental Health, Room 7147, 6001 Executive Blvd, Bethesda, MD 20892-9633, USA.
J Clin Psychiatry. 2011 Mar;72(3):388-96. doi: 10.4088/JCP.09m05885blu.
We examined the long-term outcome of participants in the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, a randomized trial of 334 adolescents (aged 12-18 years) with DSM-IV-defined major depressive disorder initially resistant to selective serotonin reuptake inhibitor (SSRI) treatment who were subsequently treated for 12 weeks with another SSRI, venlafaxine, another SSRI + cognitive-behavioral therapy (CBT), or venlafaxine + CBT. Responders then continued with the same treatment through week 24, while nonresponders were given open treatment.
For the current study, patients were reassessed 48 (n = 116) and 72 (n = 130) weeks from intake. Data were gathered from February 2001 to February 2007. Standardized diagnostic interviews and measures of depression, suicidal ideation, related psychopathology, and level of functioning were periodically administered. Remission was defined as ≥ 3 weeks with ≤ 1 clinically significant symptom and no associated functional impairment (score of 1 on the adolescent version of the Longitudinal Interval Follow-Up Evaluation [A-LIFE]), and relapse, as ≥ 2 weeks with probable or definite depressive disorder (score of 3 or 4 on the A-LIFE). Mixed-effects regression models were applied to estimate remission, relapse, and functional recovery.
By 72 weeks, an estimated 61.1% of the randomized youths had reached remission. Randomly assigned treatment (first 12 weeks) did not influence remission rate or time to remission, but the group assigned to SSRIs had a more rapid decline in self-reported depressive symptoms and suicidal ideation than those assigned to venlafaxine (P < .03). Participants with more severe depression, greater dysfunction, and alcohol or drug use at baseline were less likely to remit. The depressive symptom trajectory of the remitters diverged from that of nonremitters by the first 6 weeks of treatment (P < .001). Of the 130 participants in remission at week 24, 25.4% relapsed in the subsequent year.
While most adolescents achieved remission, more than one-third did not, and one-fourth of remitted patients experienced a relapse. More effective interventions are needed for patients who do not show robust improvement early in treatment.
clinicaltrials.gov Identifier: NCT00018902.
我们研究了治疗青少年 SSRI 抵抗性抑郁症（TORDIA）研究参与者的长期结果，这是一项针对 334 名青少年（年龄 12-18 岁）的随机试验，这些青少年患有 DSM-IV 定义的重度抑郁症，最初对选择性 5-羟色胺再摄取抑制剂（SSRIs）治疗无反应，随后接受了 12 周的另一种 SSRI、文拉法辛、另一种 SSRI+认知行为疗法（CBT）或文拉法辛+CBT 治疗。应答者随后继续接受相同的治疗至第 24 周，而无应答者则接受开放治疗。
当前研究中，患者在入组后 48（n=116）和 72（n=130）周时接受重新评估。数据收集时间为 2001 年 2 月至 2007 年 2 月。定期进行标准化诊断访谈以及抑郁、自杀意念、相关精神病理学和功能水平的评估。缓解定义为≥3 周且≤1 个临床显著症状，且无相关功能损害（青少年版纵向间隔随访评估[A-LIFE]评分为 1），复发定义为≥2 周且可能或确定为抑郁症（A-LIFE 评分为 3 或 4）。应用混合效应回归模型来估计缓解率、复发率和功能恢复率。
到 72 周时，估计有 61.1%的随机青少年达到了缓解。随机分配的治疗（前 12 周）并不影响缓解率或缓解时间，但与分配给文拉法辛的组相比，分配给 SSRI 的组的自我报告的抑郁症状和自杀意念下降更快（P<.03）。基线时抑郁程度更严重、功能障碍更大以及有酒精或药物使用史的参与者缓解的可能性较小。缓解者的抑郁症状轨迹在治疗的前 6 周就与未缓解者不同（P<.001）。在第 24 周缓解的 130 名参与者中，有 25.4%在随后的一年中复发。
虽然大多数青少年达到了缓解，但仍有超过三分之一的青少年没有缓解，四分之一的缓解患者经历了复发。对于在治疗早期没有明显改善的患者，需要更有效的干预措施。
clinicaltrials.gov 标识符：NCT00018902。
