Sonawalla Shamsah B, Farabaugh Amy H, Leslie Vinita M, Pava Joel A, Matthews John D, Fava Maurizio
Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston 20114, USA.
Prog Neuropsychopharmacol Biol Psychiatry. 2002 Apr;26(3):415-9. doi: 10.1016/s0278-5846(01)00265-2.
The purpose of this study was to assess the differences between early and late drop-outs and completers in the continuation phase of a clinical trial.
The authors studied 119 outpatients who were treatment responders in an 8-week open trial with fluoxetine 20 mg/day, and who were then enrolled in a 26-week clinical trial comparing the efficacy of fluoxetine versus fluoxetine and cognitive behavior therapy (CBT). Patients were assessed using the Structured Clinical Interview for DSM-III-R--Axis I (SCID-Patient Edition), Hamilton Depression Rating Scale (HAMD-17) and the following self-rated scales: Beck Depression Inventory (BDI), Beck Hopelessness Scale (BHS), Anxiety Sensitivity Index (ASI) and the Symptom Questionnaire (SQ) prior to starting the 26-week continuation phase. We defined "early drop-outs" (EDs) as patients who dropped out either at or prior to Visit 2 (which was at 2 months into the 6-month continuation phase); those dropping out at Visit 3 or later were defined as "late drop-outs" (LDs) (ED < or = 2 months; LD >2 months). The Kruskal-Wallis and the Mann-Whitney U tests were used for data analysis.
Of the 119 patients, 83 were completers (mean age: 42.1+/-9.0 years; 46 [55%] women; age of onset of major depressive disorder [MDD] = 24.3+/-12.5 years), II were EDs (mean age: 38.1 + 13.0 years: 4 [36%] women; age of onset of MDD = 22.0+/-11.1 years) and 25 were LDs (mean age: 35.2+/-10.4 years; 12 [48%] women; age of onset of MDD = 24.6+/-11.6 years). LDs were significantly younger than completers (P<.01). There was no significant difference in age between EDs and LDs, nor between EDs and completers. EDs were more likely to have been depressed for a longer period of time compared to LDs (P< .05). EDs completers were depressed for a longer period of time compared to LDs (P< .05).
Our data suggest that late drop-outs are significantly younger than completers, although age is not a predictor between early drop-outs and late drop-outs. Further, early drop-outs are depressed for a longer duration compared to late drop-outs completers are depressed for a longer duration than late dropouts, and Early drop-outs have significantly more social impairment compared to completers. Our study identified some patient characteristics significantly associated with dropping out of a long-term clinical trial.
本研究旨在评估在一项临床试验的延续阶段早期退出者、晚期退出者和完成者之间的差异。
作者研究了119名门诊患者，这些患者在为期8周、每天服用20毫克氟西汀的开放试验中对治疗有反应，随后参加了一项为期26周的临床试验，比较氟西汀与氟西汀联合认知行为疗法（CBT）的疗效。在开始为期26周的延续阶段之前，使用《精神疾病诊断与统计手册第三版修订本轴I障碍定式临床访谈》（SCID-患者版）、汉密尔顿抑郁评定量表（HAMD-17）以及以下自评量表对患者进行评估：贝克抑郁量表（BDI）、贝克绝望量表（BHS）、焦虑敏感性指数（ASI）和症状问卷（SQ）。我们将“早期退出者”（EDs）定义为在第2次就诊时或之前退出的患者（第2次就诊是在6个月延续阶段的第2个月）；在第3次就诊或之后退出的患者被定义为“晚期退出者”（LDs）（EDs≤2个月；LDs＞2个月）。采用Kruskal-Wallis检验和Mann-Whitney U检验进行数据分析。
119名患者中，83名完成了试验（平均年龄：42.1±9.0岁；46名[55%]为女性；重度抑郁症[MDD]发病年龄=24.3±12.5岁），11名是早期退出者（平均年龄：38.1±13.0岁；4名[36%]为女性；MDD发病年龄=22.0±11.1岁），25名是晚期退出者（平均年龄：35.2±10.4岁；12名[48%]为女性；MDD发病年龄=24.6±11.6岁）。晚期退出者明显比完成试验者年轻（P＜0.01）。早期退出者与晚期退出者之间、早期退出者与完成试验者之间年龄无显著差异。与晚期退出者相比，早期退出者抑郁时间更长（P＜0.05）。与晚期退出者相比，完成试验的早期退出者抑郁时间更长（P＜0.05）。
我们的数据表明，晚期退出者明显比完成试验者年轻，尽管年龄不是早期退出者和晚期退出者之间的预测因素。此外，与晚期退出者相比，早期退出者抑郁持续时间更长；与晚期退出者相比，完成试验者抑郁持续时间更长；与完成试验者相比，早期退出者有明显更多的社会功能损害。我们的研究确定了一些与长期临床试验退出显著相关的患者特征。
