BACKGROUND AND OBJECTIVE:Oxcarbazepine, an antiepileptic and a derivative of carbamazepine, has been shown to have clinical utility as an antimanic agent. This study sought to assess the efficacy and tolerability of oxcarbazepine compared with divalproex sodium in the treatment of patients with mania. PATIENTS AND METHODS: 57 patients from a large clinical practice who had recently begun treatment withdivalproex sodium were randomly assigned to one of two treatment groups. In this open-label, single (rater)-blind study, group 1 remained on treatment with divalproex sodium and group 2 was switched to oxcarbazepine. Both treatment groups were followed for 10 weeks after the switch. Pharmacotherapeutic efficacy was compared using the Clinician Administered Rating Scale for Mania (CARS-M). Weight and adverse events were monitored throughout the study. RESULTS: 83% of patients using oxcarbazepine showed a decrease in mania as assessed using the CARS-M, and 70% showed a net decrease in weight over the 10-week course of the study. For the divalproex sodium group, 53% showed a decrease in mania, as assessed by CARS-M, and 37% lost weight. CONCLUSION:Oxcarbazepine showed comparable efficacy to divalproex sodium, yet appeared to do so with an equal or more benign side-effect profile, particularly with regard to weight. These results suggest that oxcarbazepine, which has been used in Europe for the treatment of mood disorders for some time (albeit used off-label for this purpose) may show promise for use in the US as an agent for maintenance of non-acute mania.
RCT Entities:
BACKGROUND AND OBJECTIVE:Oxcarbazepine, an antiepileptic and a derivative of carbamazepine, has been shown to have clinical utility as an antimanic agent. This study sought to assess the efficacy and tolerability of oxcarbazepine compared with divalproex sodium in the treatment of patients with mania. PATIENTS AND METHODS: 57 patients from a large clinical practice who had recently begun treatment with divalproex sodium were randomly assigned to one of two treatment groups. In this open-label, single (rater)-blind study, group 1 remained on treatment with divalproex sodium and group 2 was switched to oxcarbazepine. Both treatment groups were followed for 10 weeks after the switch. Pharmacotherapeutic efficacy was compared using the Clinician Administered Rating Scale for Mania (CARS-M). Weight and adverse events were monitored throughout the study. RESULTS: 83% of patients using oxcarbazepine showed a decrease in mania as assessed using the CARS-M, and 70% showed a net decrease in weight over the 10-week course of the study. For the divalproex sodium group, 53% showed a decrease in mania, as assessed by CARS-M, and 37% lost weight. CONCLUSION:Oxcarbazepine showed comparable efficacy to divalproex sodium, yet appeared to do so with an equal or more benign side-effect profile, particularly with regard to weight. These results suggest that oxcarbazepine, which has been used in Europe for the treatment of mood disorders for some time (albeit used off-label for this purpose) may show promise for use in the US as an agent for maintenance of non-acute mania.
Authors: C L Bowden; J R Calabrese; S L McElroy; L Gyulai; A Wassef; F Petty; H G Pope; J C Chou; P E Keck; L J Rhodes; A C Swann; R M Hirschfeld; P J Wozniak Journal: Arch Gen Psychiatry Date: 2000-05
Authors: Robert Dent; Angelique Blackmore; Joan Peterson; Rami Habib; Gary Peter Kay; Alan Gervais; Valerie Taylor; George Wells Journal: PLoS One Date: 2012-06-15 Impact factor: 3.240