Efficacy and safety of olanzapine plus valproate in the treatment of acute mania: An open study

Objective The aim of this open study is to assess the efficacy and safety of a combination of a 20 mg/day fixed dose of olanzapine associated with a dose range of 20-25 mg/kg per day of valproate for the treatment of patients hospitalized for a manic episode with or without psychotic features. Methods: Twenty manic inpatients were treated with olanzapine (20 mg/day) and valproate (20 to 25 mg/kg per day) for 7-28 days depending on the patient response and the length of hospitalization. Patients were evaluated weekly with the Bech-Rafaelsen mania assessment scale (MAS) and the Young mania rating scale (YMRS) to monitor the symptomatology. Results: Seventeen of the 20 patients included (mean age+/-SD=41.9+/-10.6; 15 females and five males) were followed for a maximum of 28 days. The most frequent adverse events reported were weight gain (82%) and sedation (30%). At day 14, 71.4 and 64.3% of the patients were responders (response being defined as at least 50% decrease from the baseline score) based on MAS and YMRS, respectively. At end point, 87.5% of patients were responders on both scales. Conclusion: These results suggest that olanzapine and valproate combination has good efficacy and is generally well tolerated in hospitalized manic patients.