Haapasalo-Pesu Kirsi-Maria, Vuola Tapani, Lahelma Liisa, Marttunen Mauri
Adolescent Psychiatry Clinic, Hansakatu 5, FIN-28100 Pori, Finland.
J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84. doi: 10.1089/1044546041649110.
This multicenter, open-label study with a duration of 85 days was performed to evaluate the antidepressant efficacy and safety of mirtazapine (dose range, 30-45 mg) in 12-18-year-old adolescents diagnosed with major depression. Twenty-four (24) patients (15 female patients and 9 male patients) meeting the DSM-IV criteria for major depression and the Hamilton Rating Scale for Depression (HAM-D-17) score of 18 at baseline were enrolled in the study. The primary outcome measures were HAM-D-17, Beck Depression Inventory (BDI), and Clinical Global Impression (CGI) scales. Any changes in symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HAM-A). The average age of the 23 subjects, who were eligible for analysis, was 16.3 years (standard deviation (SD) 6.11, median 17.3). The mean daily dose of mirtazapine was 32.9 mg. Mirtazapine showed a marked efficacy on all rating scales and was well tolerated. Mirtazapine had a beneficial effect on sleep. A rapid onset of sleep and pattern of action was seen. No dropouts due to adverse events were recorded. The most common treatment-emergent adverse events were tiredness, increased appetite, and dizziness. The results of this study suggest that mirtazapine may be an effective treatment for major depression in adolescents.
这项为期85天的多中心、开放标签研究旨在评估米氮平（剂量范围为30 - 45毫克）对12至18岁被诊断为重度抑郁症的青少年的抗抑郁疗效和安全性。24名（15名女性患者和9名男性患者）符合DSM-IV重度抑郁症标准且基线时汉密尔顿抑郁量表（HAM-D-17）评分为18的患者被纳入该研究。主要结局指标为HAM-D-17、贝克抑郁量表（BDI）和临床总体印象（CGI）量表。使用汉密尔顿焦虑量表（HAM-A）测量焦虑症状的任何变化。23名符合分析条件的受试者的平均年龄为16.3岁（标准差（SD）6.11，中位数17.3）。米氮平的平均日剂量为32.9毫克。米氮平在所有评分量表上均显示出显著疗效，且耐受性良好。米氮平对睡眠有有益作用。观察到睡眠起效迅速且有作用模式。未记录到因不良事件导致的退出情况。最常见的治疗中出现的不良事件为疲劳、食欲增加和头晕。这项研究的结果表明，米氮平可能是青少年重度抑郁症的一种有效治疗方法。
