Clomipramine in adults with pervasive developmental disorders: A prospective open-label investigation
Clomipramine in adults with pervasive developmental disorders: A prospective open-label investigation
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DOI：
10.1089/cap.1997.7.109
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发表时间：
1997-06-01
影响因子：
1.9
通讯作者：
Price, LH
中科院分区：
文献类型：
--
作者：
Brodkin, ES;McDougle, CJ;Price, LH
这项研究的目的是确定氯丙咪嗪对一系列普适性发育障碍(PDDS)成人患者的短期疗效和耐受性。35名患有PDDS(DSM-IV)的成年人，其中16人为非语言患者，参加了为期12周的氯丙咪嗪前瞻性开放试验。最初的样本包括18名自闭症患者，6名阿斯伯格障碍患者，11名未另行指定的普及性发育障碍患者(PDDNOS)。在基线以及服用氯丙咪嗪4、8和12周后进行行为评分。在完成试验的33名患者中，有18名(55%)根据临床总体印象(Cgi)全球改善项目(p<；0.001)的“大有改善”或“大有改善”的分数被归类为治疗应答者。16例自闭症患者中有10例(63%)，6例阿斯伯格障碍患者中有2例(33%)，11例PDDNOS患者中有6例(55%)被认为对氯丙咪嗪治疗有效。在这18名患者中，氯丙咪嗪显著减少了总的重复思想和行为(p<；0.001)和攻击性(p<；0.001)，并改善了社交关系的某些方面，如眼神接触和言语反应(p<；0.001)。随着时间的推移，这些特定症状群的变化与PDD的DSM-IV亚型无关。自闭症行为量表(ABC)评分的自闭症行为水平和总智商(IQ)与总体治疗反应没有显著相关性。虽然大多数患者对氯丙咪嗪耐受性良好，但有13例患者有明显的临床不良反应。3名患者在氯丙咪嗪治疗期间出现癫痫，包括2名既往有癫痫障碍并正在服用抗惊厥药物的患者。在32名既往无癫痫史的患者中，只有1人在氯丙咪嗪治疗期间出现癫痫。没有不良的心血管或锥体外系反应。所有应答者在研究完成后继续服用氯丙咪嗪。这项开放标签试验的结果表明，氯丙咪嗪可能是一种有效的药物，可以减少重复的想法和行为以及攻击性行为，并有助于改善患有PDDS的成年人的某些社会行为因素，如眼神接触和言语反应，需要仔细监测不良反应，特别是癫痫发作。虽然在氯丙咪嗪治疗PDD患者之前，脑电(EEG)检查不是强制性的，但我们建议有癫痫病史的PDD患者最初使用选择性5-羟色胺摄取抑制剂而不是氯丙咪嗪进行治疗。这项研究的结果需要在双盲安慰剂对照研究中重复，然后才能对疗效和耐受性做出明确的声明。
The purpose of this investigation was to determine the short-term efficacy and tolerability of clomipramine in a consecutive series of adults with pervasive developmental disorders (PDDs). Thirty-five adults with PDDs (DSM-IV), 16 of whom were nonverbal, entered a 12-week prospective open-label trial of clomipramine. The initial sample included 18 patients with autistic disorder, 6 patients with Asperger's disorder, and 11 patients with pervasive developmental disorder not otherwise specified (PDDNOS). Behavioral ratings were obtained at baseline and after 4, 8, and 12 weeks of clomipramine. Eighteen (55%) of the 33 patients who completed the trial were categorized as treatment responders based on scores of ''much improved'' or ''very much improved'' on the Clinical Global Impression (CGI) global improvement item (p < 0.001). Ten (63%) of 16 patients with autistic disorder, 2 (33%) of 6 patients with Asperger's disorder, and 6 (55%) of 11 patients with PDDNOS were considered responders to clomipramine treatment. In those 18 patients, clomipramine significantly reduced total repetitive thoughts and behavior (p < 0.001) and also aggression (p < 0.001), and improved some aspects of social relatedness, such as eye contact and verbal responsiveness (p < 0.001). Change in these specific symptom clusters over time was not related to DSM-IV subtype of PDD. The level of autistic behavior, as measured by the Autism Behavior Checklist (ABC) score, and full-scale intelligence quotient (IQ) were not significantly associated with global treatment response. Whereas clomipramine was well tolerated by most patients, 13 had clinically significant adverse effects. Three patients had seizures during clomipramine treatment, including 2 who had prior seizure disorders and were taking anticonvulsants. Of the 32 patients who had no history of prior seizures, only 1 had a seizure during clomipramine treatment. There were no adverse cardiovascular or extrapyramidal effects. All responders continued on clomipramine after completion of the study. The results of this open-label trial suggest that clomipramine may be an effective drug for reducing repetitive thoughts and actions and aggressive behavior and for improving some elements of social behavior, such as eye contact and verbal responsivity in adults with PDDs, Careful monitoring of adverse effects, particularly seizures, is warranted. Although an electroencephalogram (EEG) is not mandatory in patients with PDD prior to clomipramine treatment, we recommend that patients with PDD and a history of seizures be treated initially with a selective serotonin uptake inhibitor rather than with clomipramine. The findings of this study require replication in a double-blind placebo-controlled investigation before definitive statements of efficacy and tolerability can be made.