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

NCT00308360 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2006-03-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Risperidone, divalproex

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Research Foundation for Mental Hygiene, Inc.

    collaborator OTHER

  • Nathan Kline Institute for Psychiatric Research

    lead OTHER

Principal Investigators

  • Leslie L Citrome, MD, MPH · Nathan S Kline Institute for Psychiatric Research and New York University School of Medicine

  • Jan Volavka, MD, PhD · Nathan S Kline Institute for Psychiatric Research and New York University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-30
Completion
2004-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00308360 on ClinicalTrials.gov