Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility
Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Collaborators:
Janssen, LP Research Foundation for Mental Hygiene, Inc.