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Divalproex Might Be Helpful Augmentation Strategy in Reducing Hostility: Presented at CPA

By Donalee Moulton

HALIFAX, NS -- November 3, 2003 -- The first study to compare the anti-hostility effects of adjunctive divalproex in schizophrenia has found the drug might be helpful in reducing hostility, at least initially, researchers reported at the 53^rd Annual Meeting of the Canadian Psychiatric Association, held October 30^th to November 2^nd in Halifax, Nova Scotia, Canada.

"There are expert consensus guidelines suggesting the use of adjunctive valproate (the active moiety of valproic acid and divalproex sodium) in patients with schizophrenia with agitation, excitement, aggression or violence," said principal investigator Leslie Citrome, MD, clinical professor of psychiatry, New York University, Research Director, Nathan Kline Institute, New York.

A 4-week, double blind, parallel group, clinical trial was conducted in 29 centres throughout the United States over 28 days to compare the anti-hostility effects of atypical antipsychotic monotherapy, specifically olanzapine or risperidone, to combination treatment with divalproex in patients experiencing an acute schizophrenic episode. In all, 249 patients were randomly assigned to one of four groups: olanzapine and placebo; olanzapine and divalproex; risperidone and placebo; or risperidone and divalproex.

Of the initial participant cohort, 166 patients (67%) completed the study.

The Positive and Negative Syndrome Scale (PANSS) hostility item was the main outcome measure used to assess differences between the monotherapy and combination therapy groups.

In the first week of treatment, mean changes from baseline were 0.3 for monotherapy and 0.7 for combination therapy. Combination therapy also resulted in significantly greater effect on anti-hostility at both Day 3 and Day 7 than did monotherapy (0.020 and 0.005). This significant effect, however, was short in duration.

"Statistical significance was not seen beyond the first week of treatment, but there was a trend towards a difference between combination treatment versus antipsychotic monotherapy when repeated measures were utilised over Days 1 through 28," said Dr. Citrome. However, he added, the treatments appear to converge over time.

Despite the convergence, the researchers concluded that adjunctive divalproex might be a helpful augmentation strategy for reducing hostility.


[Study title: Effects of Adjunctive Valporate on Hostility in Patients with Schizophrenia Receiving Olanzapine or Risperidone: A Double-Blind Multi-Center Study. Abstract P1-2]

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