Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY 11004-1150, USA.
J Clin Psychiatry. 2010 Nov;71(11):1475-81. doi: 10.4088/JCP.09m05950gry. Epub 2010 Aug 24.
To evaluate the efficacy and tolerability of armodafinil, the longer-lasting isomer of modafinil, as adjunctive therapy in patients with schizophrenia.
This 4-week, randomized, double-blind, placebo-controlled, proof-of-concept study was conducted between July and December 2007. Patients had a history of stable schizophrenia (DSM-IV-TR criteria) for ≥ 8 weeks and were treated with oral risperidone, olanzapine, or paliperidone for ≥ 6 weeks at stable doses for ≥ 4 weeks. Patients were randomly assigned to once-daily placebo or armodafinil 50, 100, or 200 mg. The primary efficacy measure was the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery. Secondary outcome measures included the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
Sixty patients were randomly assigned (15 in each group). No apparent differences between groups in the MATRICS composite score were observed (mean ± SD change from baseline to final visit: armodafinil 50 mg, 1.9 ± 6.22; 100 mg, 2.8 ± 7.98; 200 mg, 2.9 ± 4.72; placebo, 2.2 ± 5.06). The mean ± SD changes in PANSS total scores were -6.3 ± 7.25 for armodafinil 200 mg and -1.7 ± 4.89 for placebo at final visit (effect size=0.73; 95% CI, -0.08 to 1.54) and PANSS negative symptoms scores were -3.4 ± 2.07 and 0.1 ± 1.93 (effect size=1.69; 95% CI, 0.78 to 2.60), respectively. Although reductions in SANS total score were observed with both armodafinil and placebo at final visit, no between-group difference was shown. Armodafinil was generally well tolerated, with diarrhea and headache the most commonly reported adverse events. There was no evidence of worsening of psychosis with adjunctive armodafinil.
In this 4-week study, adjunctive armodafinil was not associated with an improvement in cognitive measures, but armodafinil 200 mg/d appeared to mitigate the negative symptoms of schizophrenia. Treatment was generally well tolerated.
clinicaltrials.gov Identifier: NCT00487942.
评估阿莫达非尼（莫达非尼的长效异构体）作为精神分裂症辅助治疗的疗效和耐受性。
这是一项为期 4 周的随机、双盲、安慰剂对照的概念验证研究，于 2007 年 7 月至 12 月进行。患者有稳定的精神分裂症病史（DSM-IV-TR 标准）≥8 周，且在稳定剂量下接受利培酮、奥氮平或帕利哌酮治疗≥6 周，时间≥4 周。患者被随机分配接受每日一次安慰剂或阿莫达非尼 50、100 或 200mg。主要疗效指标是精神分裂症认知测量和治疗研究（MATRICS）共识认知电池。次要结局指标包括阳性和阴性症状量表（PANSS）和阴性症状评定量表（SANS）。
60 名患者被随机分配（每组 15 名）。在 MATRICS 综合评分方面，各组之间没有明显差异（从基线到最后一次就诊的平均变化±标准差：阿莫达非尼 50mg，1.9±6.22；100mg，2.8±7.98；200mg，2.9±4.72；安慰剂，2.2±5.06）。最后一次就诊时，阿莫达非尼 200mg 和安慰剂的 PANSS 总分平均变化分别为-6.3±7.25 和-1.7±4.89（效应量=0.73；95%置信区间，-0.08 至 1.54），PANSS 阴性症状评分分别为-3.4±2.07 和 0.1±1.93（效应量=1.69；95%置信区间，0.78 至 2.60）。尽管最后一次就诊时阿莫达非尼和安慰剂均观察到 SANS 总分降低，但组间无差异。阿莫达非尼总体耐受性良好，最常见的不良反应是腹泻和头痛。没有证据表明辅助使用阿莫达非尼会加重精神病。
在这项为期 4 周的研究中，辅助使用阿莫达非尼与认知测量的改善无关，但阿莫达非尼 200mg/d 似乎可以减轻精神分裂症的阴性症状。治疗总体上耐受性良好。
clinicaltrials.gov 标识符：NCT00487942。
