Impact of Comorbidity on treatment response to paroxetine in pediatric obsessive-compulsive disorder: Is the use of exclusion criteria empirically supported in randomized clinical trials?
Impact of Comorbidity on treatment response to paroxetine in pediatric obsessive-compulsive disorder: Is the use of exclusion criteria empirically supported in randomized clinical trials?
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DOI：
10.1089/104454603322126313
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发表时间：
2003-01-01
影响因子：
1.9
通讯作者：
Carpenter, D
中科院分区：
文献类型：
--
作者：
Geller, DA;Biederman, J;Carpenter, D
目的：研究精神共病对帕罗西汀治疗儿童和青少年强迫症（OCD）的反应和复发率的影响。方法：治疗16周后（D期）有反应的患者随机继续帕罗西汀或安慰剂治疗16周（11期）。强迫症反应（D期）和复发（11期）标准基于临床总体印象改善量表和儿童耶鲁-布朗强迫量表。强迫症和其他精神疾病的存在，确定使用儿童情感障碍和精神分裂症的学龄儿童，目前和终身版本interview.Results：在入口处，193 335（57.6%）的患者至少有一个精神疾病，除了强迫症，和102 335（30.4%）有多种其他疾病。尽管帕罗西汀在总体人群中的应答率很高（71%），但在合并有注意缺陷多动障碍、抽动障碍或对立违抗性障碍的患者中，（分别为56%、53%和39%）显著低于仅患有强迫症的患者（75%）（意向治疗人群，末次观察值结转分析，p < 0.05）。精神共病与总患者人群中较高的复发率相关（46%的人患有一种或多种共病[p = 0.04]，56%的人患有两种或多种共病[p < 0.05]，而无共病的人为32%）。结论：这些事后分析的结果表明，共病对儿童强迫症患者帕罗西汀药物治疗的反应有不良影响，在退出治疗后复发的风险显著增加。与安慰剂组相比，继续帕罗西汀治疗降低了所有组的复发率，包括那些患有共病的患者。由于儿童强迫症经常与其他精神疾病共病，使用多种排除标准的随机对照儿童强迫症试验的结果可能无法推广到更自然的强迫症样本。
Objective: To examine the influence of psychiatric comorbidity on response and relapse rates in children and adolescents treated with paroxetine for obsessive-compulsive disorder (OCD).Methods: Patients responding following 16 weeks of treatment (phase D were randomized to continued paroxetine or to placebo for 16 additional weeks (phase 11). OCD response (phase D and relapse (phase 11) criteria were based on the Clinical Global Impression Improvement Scale and the Children's Yale-Brown Obsessive Compulsive Scale. The presence of OCD and other psychiatric disorders was ascertained using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version interview.Results: At entry, 193 of 335 (57.6%) patients had at least one psychiatric disorder in addition to OCD, and 102 of 335 (30.4%) had multiple other disorders. Although the response rate to paroxetine in the overall population was high (71%), the response rates in patients with comorbid attention deficit hyperactivity disorder, tic disorder, or oppositional defiant disorder (56%, 53%, and 39%, respectively) were significantly less than in patients with OCD only (75%) (intent-to-treat population, last observation carried forward analysis, p < 0.05). Psychiatric comorbidity was associated with a greater rate of relapse in the total patient population (46% for one or more comorbid disorders [p = 0.04] and 56% for two or more comorbid disorders [p < 0.05] vs. 32% for no comorbidity).Conclusions: The results of these post hoc analyses show that comorbid illness adversely impacted response to pharmacotherapy with paroxetine in pediatric OCD and significantly increased risk of relapse following withdrawal from treatment. Continued paroxetine treatment reduced relapse rates in all groups compared with placebo, including those with comorbid illness. Because pediatric OCD is frequently comorbid with other psychiatric disorders, results of randomized, controlled pediatric OCD trials that use multiple exclusion criteria may not generalize to more naturalistic OCD samples.