Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility

Summary

This is an eight-week open-label randomized parallel group clinical trial focusing on the comparison of risperidone alone with risperidone plus valproate among hospitalized adult patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may have already been receiving risperidone or valproate (but not both) at study entry. Patients not receiving valproate at study entry were randomized to receive either risperidone alone or risperidone with valproate. For patients already receiving valproate at study entry, their antipsychotic medication(s) was switched to risperidone, and they were followed for a four-week lead-in period prior to baseline assessment and randomization to receive risperidone alone or continue with risperidone and valproate. We hypothesized that risperidone alone has an antiaggressive/antihostility effect, and that this effect is augmented by the co-administration of valproate.

Timeline

Start

1999-09

Primary completion

—

Completion

2004-04

Publications

• Citrome L, Shope CB, Nolan KA, Czobor P, Volavka J. Risperidone alone versus risperidone plus valproate in the treatment of patients with schizophrenia and hostility. Int Clin Psychopharmacol. 2007 Nov;22(6):356-62. doi: 10.1097/YIC.0b013e3281c61baf.

Drugs

Indications