Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00308360
Brief 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.
Detailed Description:
Background: Patients with schizophrenia who also exhibit hostile behavior pose a formidable challenge for clinicians. Hostile behavior is a frequent reason for psychiatric admission, and is an obstacle for the successful reintegration of patients back into the community. Current treatment approaches have generally not been assessed under controlled conditions.
Method: 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. Blinded raters completed a battery of assessments, including the Positive and Negative Syndrome Scale, Buss-Durkee Hostility Inventory, Barratt Impulsiveness Scale, and the Overt Aggression Scale. We hypothesized that risperidone alone has an antiaggressive/antihostility effect, and that this effect is augmented by the co-administration of valproate.
Study:
NCT00308360
Study Brief:
Protocol Section:
NCT00308360