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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.

In spring 2000, the Missouri Department of Mental Health mandated that its psychiatric inpatient facilities convert patients from trade-name to generic clozapine. The pharmacy department at our facility was encouraged to develop a conversion program to oversee and assess the efficacy and tolerability of the change. A protocol to monitor the conversion of patients to generic clozapine hospitalwide was developed. The primary objective was to determine whether therapeutic response and level of tolerability were the same with generic versus trade-name clozapine. The secondary objective was to determine whether changes in monitoring white blood cell and absolute neutrophil counts were necessary after conversion. Our results showed that most patients did not experience changes greater than a mean of 5 points in their scores on the Brief Psychiatric Rating Scale (BPRS). However, a statistically significant difference was seen in 22 patients who had a mean reduction or an increase of less than 5 points (p=0.0139) in BPRS scores compared with two patients who had a mean increase greater than 5 points. Assessment of percentage change in BPRS scores indicated that 14 (58%) converted patients had a 1-50% decrease in mean BPRS scores, and 10 (42%) had a 1-40% increase. However, of those with a mean BPRS increase, five (50%) had an increase of 10% or less. Our clozapine conversion program resulted in the successful conversion of all 24 patients.