Extended-release divalproex sodium for mood stabilization.

Study Objective: To evaluate the efficacy, safety, and tolerability of extended-release divalproex sodium.

Design: Prospective, open-label, 4-week study

Setting: Long-term care facility of the Missouri Department of Mental Health.

Patients: Ten hospitalized patients (mean age 39.4 yrs) with mood or thought disorders who were experiencing adverse effects from delayed-release divalproex sodium.

Intervention: All participants were switched from delayed-release to extended-release divalproex sodium.

Measurements And Main Results: Efficacy was monitored with the Brief Psychiatric Rating Scale (BPRS), and safety and tolerability were monitored with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Frequently reported adverse effects before conversion were sedation, stomach upset, and tremor. At study conclusion, no differences were seen in total BPRS scores or individual BPRS items, although a trend pointed to decreased somatic complaints (p=0.057). The mean serum concentration of valproic acid among participants did not change significantly in the transition from the delayed-release formulation to an equivalent dose-adjusted extended-release formulation (90.5 mg/L vs 95.5 mg/L, p=0.493). At study conclusion, significant decreases in low-density lipoprotein cholesterol (p=0.010) and potassium (p=0.043) levels were identified. Three categories of adverse effects decreased significantly after patients switched to the extended-release form of divalproex sodium: sedation (p=0.022), stomach or abdominal discomfort (p=0.045), and tremor (p=0.004).

Conclusion: This preliminary investigation suggests that patients receiving delayed-release divalproex sodium for mood lability can be converted successfully to extended-release divalproex sodium. Moreover, these findings imply that this transition is associated with a reduction in some of the adverse effects associated with divalproex sodium.