Valproate (depakine-chrono) in the acute treatment of outpatients with generalized anxiety disorder without psychiatric comorbidity: randomized, double-blind placebo-controlled study.

OBJECTIVE: Anxiety disorders are highly prevalent in population of European countries. However, the effect of Valproate (depakine-chrono) on generalized anxiety disorder (GAD) has not been studied in a double-blind placebo-controlled design.

METHOD: Eighty patients (all men) were washout from the all medications. Each patient was randomized to receive either depakine-chrono (40 patients) for 6 weeks or matched placebo (40 patients) in a double-blind manner. Eligible participants, in addition to meeting the DSM-IV criteria for GAD and having a minimum score of 25 and more on the Hamilton Anxiety Scale, were required to be between 18 and 65 years. Response was defined as a 50% reduction in the Hamilton anxiety scale score. Response and side effects with depakine-chrono and placebo were compared by using analysis of variance (ANOVA) and chi-square tests. Six patients did not return for at least one subsequent assessment, leaving 74 patients (36 taking depakine-chrono and 38 taking placebo) in the valuables study group.

RESULTS: Twenty six of the 36 depakine-chrono-treated participants responded by 6 weeks, versus six of the 38 placebo-treated participants (p<0.001). The most common and problematic side effect in the depakine-chrono group was dizziness and nausea.

CONCLUSIONS: The authors believe this to be the first double-blind placebo-controlled randomization study to test the efficacy of a depakine-chrono in the management of anxiety disorders. They need to be replicated in a larger study group.