This parallel-group, 24-week study enrolled adults with schizophrenia who were receiving oral olanzapine, risperidone, or paliperidone for ?#xA0;6 weeks, and had a Positive and Negative Syndrome Scale (PANSS) negative symptom subscale score of ?#xA0;15. Patients received one of 3 doses of once-daily armodafinil (150 mg, 200 mg, or 250 mg) or placebo. The primary efficacy measure was the change from baseline to final visit in the PANSS negative symptom subscale score. Secondary measures included the PANSS total score, Clinical Global Impression of Severity, Personal and Social Performance Scale, and CNSVitalSigns cognitive battery.
Of 285 randomized patients, 213 received armodafinil and 72 received placebo. The mean (SD) changes in PANSS negative symptom subscale score were ?#xA0;1.9 (3.8) for armodafinil 150 mg (n = 70), -2.3 (3.6) for armodafinil 200 mg (n = 69), -2.0 (3.3) for armodafinil 250 mg (n = 71), and ?#xA0;2.2 (4.1) for placebo (n = 70) (p ?#xA0;0.70 for each armodafinil group versus placebo). Secondary measures were generally not different between groups. Armodafinil was generally well tolerated, without worsening positive symptoms.
This study found no benefit of adjunctive armodafinil versus placebo for negative symptoms in patients with schizophrenia receiving treatment with olanzapine, risperidone, or paliperidone. Armodafinil was generally well tolerated in these patients.
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址:北京市海淀区学院路29号 邮编:100083 电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700 |