在初始 SSRI 治疗无效后改用第二种抗抑郁药时的预期：来自随机临床试验 STAR*D 的报告。

What to Expect When Switching to a Second Antidepressant Medication Following an Ineffective Initial SSRI: A Report From the Randomized Clinical STAR*D Study.

机构信息

Duke-National University of Singapore, Singapore, Singapore.

Department of Psychiatry, Texas Tech University Health Sciences Center, Odessa, Texas, USA.

出版信息

J Clin Psychiatry. 2020 Aug 11;81(5):19m12949. doi: 10.4088/JCP.19m12949.

DOI:10.4088/JCP.19m12949

PMID:32780949

Abstract

OBJECTIVE

An antidepressant medication switch often follows a failed initial trial with selective serotonin reuptake inhibitors (SSRIs). When, for whom, and how often second-step response and remission occur are unclear, as is preferred second-step trial duration. As more treatments are approved for use following 2 failed "adequate" trials, researchers and clinicians require an evidence-based definition of "adequate."

METHODS

Following citalopram in the randomized Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial (which ran July 2001-September 2006), participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR₁₆) were randomized to bupropion sustained release, sertraline, or venlafaxine extended release (up to 14 weeks). The QIDS-SR₁₆ defined response, remission, and no clinically meaningful benefit based on the modified intent-to-treat sample.

RESULTS

About 80% of 438 participants completed ≥ 6 weeks of treatment with the switch medication. All treatments had comparable outcomes. Overall, 21% (91/438) remitted, 9% (40/438) responded without remission, and 58% (255/438) had no meaningful benefit. Half of the responses and two-thirds of remissions occurred after 6 weeks of treatment. Overall, 33% of responses (43/131) occurred after ≥ 9 weeks of treatment. No baseline features differentiated early from later responders or remitters. No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR₁₆ score around week 2 were 6 times more likely to respond or remit than those without this reduction.

CONCLUSIONS

Following nonefficacy with an initial SSRI, only about 20% remit and more than half achieve no meaningful benefit with a second-step switch to another monoaminergic antidepressant. A 12-week trial duration seems necessary to capture as many second-step switch responders as possible.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00021528.

摘要

目的

在选择性 5-羟色胺再摄取抑制剂（SSRIs）初始治疗失败后，通常会进行抗抑郁药物转换。目前尚不清楚第二步反应和缓解发生的时间、人群以及频率，也不清楚第二步试验的最佳持续时间。随着越来越多的治疗方法在两次“充分”试验失败后被批准使用，研究人员和临床医生需要一个基于证据的“充分”定义。

方法

在随机序贯治疗选择缓解抑郁（STAR*D）临床试验（2001 年 7 月至 2006 年 9 月进行）中，西酞普兰治疗后，16 项快速抑郁症状自评量表-自我报告（QIDS-SR₁₆）评分≥11 的参与者被随机分配至安非他酮缓释片、舍曲林或文拉法辛缓释片（最长 14 周）。根据修改后的意向治疗样本，QIDS-SR₁₆ 定义了反应、缓解和无临床意义获益。

结果

约 438 名参与者中的 80%完成了切换药物的治疗≥6 周。所有治疗的结果都相当。总体而言，21%（91/438）缓解，9%（40/438）有反应但未缓解，58%（255/438）无明显获益。约一半的反应和三分之二的缓解发生在治疗 6 周后。总体而言，33%的反应（43/131）发生在治疗≥9 周后。没有基线特征可以区分早期和晚期反应者或缓解者。没有发现早期分诊点，但那些在 QIDS-SR₁₆ 评分第 2 周左右基线降低至少 20%的患者，比没有这种降低的患者有 6 倍的可能性出现反应或缓解。