Allergan plc, 5 Giralda Farms, Madison, NJ, 07940, USA.
Johns Hopkins University and Kennedy Krieger Institute, Baltimore, Maryland, USA.
Paediatr Drugs. 2018 Aug;20(4):353-363. doi: 10.1007/s40272-018-0290-4.
Major depressive disorder (MDD) is a serious illness in children and adolescents. Vilazodone is a selective serotonin reuptake inhibitor approved for MDD in adults. This study evaluated the efficacy, safety, and tolerability of vilazodone in adolescent patients, ages 12-17 years, with MDD (NCT01878292).
This double-blind, randomized, placebo-controlled, parallel-group, fixed-dose study was conducted at 56 study centers in the United States and was 10 weeks in duration (a 1-week screening period, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period). Outpatients with an MDD diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria were included in the study. Clinical inclusion criteria required a Children's Depression Rating Scale-Revised (CDRS-R) total score of ≥ 40 and Clinical Global Impressions-Severity (CGI-S) score of ≥ 4. Patients were randomized 1:1:1 to 8 weeks of double-blind treatment with placebo (n = 174), vilazodone 15 mg/day (n = 175), or vilazodone 30 mg/day (n = 180). The primary and secondary efficacy parameters were change from baseline to week 8 in CDRS-R total score and CGI-S score, respectively. Safety parameters included adverse events (AEs); clinical laboratory, vital sign, and electrocardiogram parameters; and the Columbia-Suicide Severity Rating Scale.
Approximately 86% of patients completed double-blind treatment. There was no statistically significant difference between vilazodone 15 mg/day or 30 mg/day and placebo in change from baseline in CDRS-R score. Change in CGI-S score was not significant after adjustment for multiple comparisons. The most common treatment-emergent AEs were nausea, upper abdominal pain, vomiting, diarrhea, nasopharyngitis, headache, and dizziness. Reports of suicidal ideation (placebo, 33.3%; vilazodone 15 mg/day, 36.0%; vilazodone 30 mg/day, 31.1%) and suicidal behavior (placebo, 1.8%; vilazodone 15 mg/day, 1.1%; vilazodone 30 mg/day, 1.1%) were similar between treatment groups. There were no deaths in the study.
The efficacy of vilazodone for the treatment of MDD in adolescent patients could not be confirmed in this study. Vilazodone was generally safe and well tolerated, with treatment-emergent AEs similar to those in adult patients.
NCT01878292.
重度抑郁症（MDD）是儿童和青少年的严重疾病。维拉佐酮是一种已被批准用于成人 MDD 的选择性 5-羟色胺再摄取抑制剂。本研究评估了维拉佐酮在 12-17 岁 MDD 青少年患者中的疗效、安全性和耐受性（NCT01878292）。
这项双盲、随机、安慰剂对照、平行组、固定剂量研究在美国的 56 个研究中心进行，持续 10 周（1 周筛选期、8 周双盲治疗期和 1 周双盲减量期）。符合《精神障碍诊断与统计手册》第四版修订版（DSM-IV-TR）标准的 MDD 诊断的门诊患者被纳入研究。临床纳入标准要求儿童抑郁评定量表修订版（CDRS-R）总分≥40 和临床总体印象严重程度（CGI-S）评分≥4。患者以 1:1:1 的比例随机分为安慰剂（n=174）、维拉佐酮 15mg/天（n=175）或维拉佐酮 30mg/天（n=180）组，接受 8 周双盲治疗。主要和次要疗效参数分别为 CDRS-R 总分和 CGI-S 评分从基线到第 8 周的变化。安全性参数包括不良事件（AE）；临床实验室、生命体征和心电图参数；以及哥伦比亚自杀严重程度评定量表。
约 86%的患者完成了双盲治疗。维拉佐酮 15mg/天或 30mg/天与安慰剂相比，在 CDRS-R 评分从基线的变化方面没有统计学上的显著差异。经多次比较调整后，CGI-S 评分的变化无显著意义。最常见的治疗相关不良事件为恶心、上腹痛、呕吐、腹泻、鼻咽炎、头痛和头晕。报告的自杀意念（安慰剂 33.3%；维拉佐酮 15mg/天 36.0%；维拉佐酮 30mg/天 31.1%）和自杀行为（安慰剂 1.8%；维拉佐酮 15mg/天 1.1%；维拉佐酮 30mg/天 1.1%）在治疗组之间相似。研究中无死亡病例。
本研究不能证实维拉佐酮治疗青少年 MDD 的疗效。维拉佐酮通常是安全且耐受良好的，与成人患者的治疗相关不良事件相似。
NCT01878292。
