Placebo-controlled study of divalproex sodium for agitation in dementia.
The authors assessed the efficacy, tolerability, and safety of divalproex sodium for the treatment of agitation associated with dementia in a 6-week, randomized study of 56 nursing home patients with agitation and dementia treated with either placebo or individualized doses of divalproex sodium. Participants were blinded to treatment except for a physician-monitor and a pharmacist. When several covariates were taken into account, the drug/placebo difference in Brief Psychiatric Rating Scale Agitation scores became statistically significant (P=0.05). Sixty-eight percent of patients on divalproex were rated as showing reduced agitation on the Clinical Global Impression scale, vs. 52% on placebo (P=0.06 in the adjusted analysis). Side effects occurred in 68% of the divalproex group vs. 33% of the placebo group (P=0.03) and were generally rated as mild. This placebo-controlled study, despite some limitations, suggests possible short-term efficacy, tolerability, and safety of divalproex for agitation in dementia and supports further placebo-controlled studies.
Porsteinsson
A P
AP
Department of Psychiatry and Program in Neurobehavioral Therapeutics, Monroe Community Hospital, Rochester, NY 14620, USA. antonp@frontiernet.net
Tariot
P N
PN
Erb
R
R
Cox
C
C
Smith
E
E
Jakimovich
L
L
Noviasky
J
J
Kowalski
N
N
Holt
C J
CJ
Irvine
C
C
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000494:pharmacology; D003704:Dementia / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011595:Psychomotor Agitation / Q000188:drug therapy* / Q000209:etiology; D012044:Regression Analysis; D018709:Statistics, Nonparametric; D014635:Valproic Acid / Q000008:administration & dosage* / Q000494:pharmacology
D018692:Antimanic Agents; D014635:Valproic Acid