Porsteinsson Anton P, Tariot Pierre N, Jakimovich Laura J, Kowalski Nancy, Holt Connie, Erb Rosemary, Cox Christopher
Department of Psychiatry, Program in Neurobehavioral Therapeutics, University of Rochester Medical Center and Monroe Community Hospital, tochester, NY 14620, USA.
Am J Geriatr Psychiatry. 2003 Jul-Aug;11(4):434-40.
The authors describe an open-label extension of a double-blind, randomized, placebo-controlled study of divalproex sodium in 56 nursing home patients with agitation and dementia.
Participants (N=46) were treated for 6 weeks in an open fashion with clinically optimal doses of divalproex sodium (range: 250 mg/day-1,500 mg/day; mean: 851 mg/day). Behavior was assessed with the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression of Change (CGI) by new raters. Safety, tolerability, and laboratory data were obtained regularly.
The mean BPRS Agitation Factor decreased by 3.1 points from baseline; 86% of those completing the open phase were rated as improved on the CGI. These changes were mirrored by changes in other behavior rating scales. Sixty percent of subjects had no side effects; 33% had side effects that were rated as mild. There were no clinically significant changes in laboratory values.
Ongoing open-label treatment with divalproex was associated with improvement in measures of agitation. Doses, levels, and tolerability were similar to those in the blinded phase of the study. These findings help confirm and extend the results from the placebo-controlled phase of the trial and suggest that divalproex may be beneficial for some patients with this clinical problem.
作者描述了一项针对56名患有激越和痴呆的疗养院患者进行的双盲、随机、安慰剂对照丙戊酸钠研究的开放标签扩展研究。
参与者（N = 46）以开放方式接受了6周的临床最佳剂量丙戊酸钠治疗（范围：250毫克/天 - 1500毫克/天；平均：851毫克/天）。新评估者使用简明精神病评定量表（BPRS）和临床总体印象变化量表（CGI）对行为进行评估。定期获取安全性、耐受性和实验室数据。
BPRS激越因子的平均值较基线下降了3.1分；完成开放阶段的患者中，86%在CGI上被评定为有所改善。其他行为评定量表的变化也反映了这些改变。60%的受试者无副作用；33%有被评定为轻度的副作用。实验室值无临床显著变化。
持续使用丙戊酸钠进行开放标签治疗与激越测量指标的改善相关。剂量、血药浓度和耐受性与研究的盲法阶段相似。这些发现有助于证实和扩展试验安慰剂对照阶段的结果，并表明丙戊酸钠可能对一些患有此临床问题的患者有益。
