A study of the safety, efficacy, and tolerability of switching from the standard delayed release preparation of divalproex sodium to the extended release formulation in patients with schizophrenia.

摘要: OBJECTIVE To assess the safety, efficacy, and tolerability of switching from a multiple dose preparation divalproex sodium delayed release (DR) to once-daily dosing with extended (ER) in patients schizophrenia already receiving standard DR formulation. METHOD Thirty subjects were switched 4-week open-label treatment trial ER Baseline plasma levels valproate obtained 12 hours postdose. Patients converted on 1.0:1.0 mg basis (rounded up nearest 500-mg increment) if baseline > or =85 microg/mL; otherwise, conversion rate was 1.0:1.2 rounded up. Measured at end point Brief Psychiatric Rating Scale Udvalg for Kliniske Undersogelser Side Effect Scale. End both 24 RESULTS who had small (and probably clinically insignificant) improvement noted total (mean change +/- SD = -2.3 5.4; t -2.2538; df 28; P 0.0322) change+/- -2.2+/- 4.1; -2.7361; 26; 0.0111). trough 80.1 20.4 73.1 24.2 microg/mL, respectively. lower than but did not experience deterioration their psychopathology. For all patients, peak statistically significantly different (t -3.8706; 27; 0.0006), these differences magnitude 14.6 +/-19.6 microg/mL). Seven experienced spontaneously reported adverse events, none required early termination protocol. CONCLUSIONS Switching formulation can be accomplished without The appears well tolerated. A parallel group design will necessary confirm findings.