OBJECTIVE: The authors describe an open-label extension of a double-blind, randomized, placebo-controlled study of @entity1092 in 56 nursing home @entity1 with @entity2146 and @entity303 . METHODS: @entity1 (N=46) were treated for 6 weeks in an open fashion with clinically optimal doses of divalproex @entity1372 (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. RESULTS: 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. CONCLUSION: Ongoing open-label treatment with divalproex was associated with improvement in measures of @entity2146 . 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 @entity1 with this clinical problem.

@entity1092 therapy for @entity2146 in XXXX : open-label extension of a double-blind trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'Participants'] @entity303 :: ('MESH:D003704', 'Disease') :: ['dementia'] @entity1092 :: ('MESH:D014635', 'Chemical') :: ['divalproex sodium'] @entity1372 :: ('MESH:D012964', 'Chemical') :: ['sodium'] @entity2146 :: ('MESH:D011595', 'Disease') :: ['agitation']
@entity303 :: (MESH:D003704,Disease) :: ['dementia']
