ADI International Institute for Advancement of Drug Development, Basel, Switzerland.
Int J Psychiatry Clin Pract. 2006;10(2):124-30. doi: 10.1080/13651500600579175.
Objective. The purpose of the present study was to document the experience with the use of a new, fast-dissolving oral tablet (FDT, RemeronSolTab®) of mirtazapine, a NaSSA antidepressant, in the treatment of depressed patients in daily practice in Switzerland. Methods. It was an open, prospective collection of observations in a total of 1121 depressive patients (>18 years old, both sexes). The treatment duration was 8 weeks with assessments after the second and eighth week. Efficacy measures were CGI (seven points) and specific check-lists for the ratings of severity of anxiety and sleep disturbances. At the end of the trial the acceptance (eight-item questionnaire) of the new formulation was recorded too. Results. The results showed that there was highly significant (P<0.001) and rapid improvement of severity of depression, anxiety and sleep disturbances in the whole population. Subgroup analyses showed that the antidepressant efficacy was independent of gender, initial severity of depression or of the type of depression (first episode, recurrent, chronic depression). The majority of patients (80%) liked at least one of the properties of FDT and, out of 75% of patients having experience with conventional tablet, 50% stated to be better compliant with this new formulation. Conclusion. This report documents the antidepressant efficacy of mirtazapine FDT. The new formulation found good acceptance by the patients. The results also suggest a likelihood of improved compliance with the mirtazapine FDT.
目的。本研究旨在记录使用新型速溶口腔片剂(FDT,RemeronSolTab®)米氮平(NaSSA 类抗抑郁药)治疗瑞士日常实践中抑郁患者的经验。
方法。这是一项针对 1121 例(年龄>18 岁,男女)抑郁患者的开放性、前瞻性观察研究。治疗持续 8 周,分别在第 2 周和第 8 周后进行评估。疗效评估采用 CGI(七点)和特定的焦虑及睡眠障碍严重程度评估清单。试验结束时,还记录了对新配方的接受程度(八问问卷)。
结果。结果显示,所有患者的抑郁、焦虑和睡眠障碍严重程度均有显著(P<0.001)且快速改善。亚组分析表明,抗抑郁疗效与性别、抑郁初始严重程度或抑郁类型(首发、复发性、慢性抑郁)无关。大多数患者(80%)至少喜欢 FDT 的一个特性,在有常规片剂使用经验的 75%的患者中,有 50%表示对这种新配方更有依从性。
结论。本报告记录了米氮平 FDT 的抗抑郁疗效。新配方得到了患者的良好认可。结果还表明,米氮平 FDT 的依从性可能得到改善。