Abstract
Objective: 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. Methods: 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. 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 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 434-440 |
| Number of pages | 7 |
| Journal | American Journal of Geriatric Psychiatry |
| Volume | 11 |
| Issue number | 4 |
| DOIs | |
| State | Published - 2003 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Psychiatry and Mental health
- Geriatrics and Gerontology
Cite this
Valproate therapy for agitation in dementia : Open-label extension of a double-blind trial. / Porsteinsson, Anton P.; Tariot, Pierre N.; Jakimovich, Laura J.; Kowalski, Nancy; Holt, Connie; Erb, Rosemary; Cox, Christopher.
In: American Journal of Geriatric Psychiatry, Vol. 11, No. 4, 2003, p. 434-440.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Valproate therapy for agitation in dementia
T2 - Open-label extension of a double-blind trial
AU - Porsteinsson, Anton P.
AU - Tariot, Pierre N.
AU - Jakimovich, Laura J.
AU - Kowalski, Nancy
AU - Holt, Connie
AU - Erb, Rosemary
AU - Cox, Christopher
PY - 2003
Y1 - 2003
N2 - Objective: 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. Methods: 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. 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 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.
AB - Objective: 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. Methods: 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. 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 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.
UR - http://www.scopus.com/inward/record.url?scp=0038679746&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0038679746&partnerID=8YFLogxK
U2 - 10.1097/00019442-200307000-00006
DO - 10.1097/00019442-200307000-00006
M3 - Article
VL - 11
SP - 434
EP - 440
JO - American Journal of Geriatric Psychiatry
JF - American Journal of Geriatric Psychiatry
SN - 1064-7481
IS - 4
ER -