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

NCT00308360 | Completed Phase 4

• 1 other identifier: RIS-189
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Hostility; Impulsivity; Aggression

Outcome Measures

Primary Outcomes (2)

• Buss-Durkee Hostility Inventory

• Barratt Impulsiveness Scale

Secondary Outcomes (2)

• Overt Aggression Scale

• Positive and Negative Syndrome Scale

Interventions

Risperidone, divalproex DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Male or female, age 18 to 65 inclusive, diagnosed with schizophrenia (not including schizoaffective disorder) according to DSM-IV criteria using the Structured Clinical Interview for DSM-IV Axis I Disorders; 2) Referral from the treating psychiatrist/treatment team because of difficulties with poor impulse control; 3) At study entry the subject must have scored at least "3" ("mild" or above) on at least one of the following Positive and Negative Syndrome Scale items that comprise the activation factor: Hostility, Impulsivity, Excitement, or Uncooperativeness; 4) Capacity and willingness to give informed consent; 5) Adequate knowledge of English; 6) Absence of serious medical illness; and 7) Accessible, adequate veins likely to permit repeated venipunctures without major problems.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• Janssen, LP: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator

Study Sites (1)

Nathan S Kline Institute for Psychiatric Research and Rockland Psychiatric Center, Clinical Research and Evaluation Facility

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

• 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.

  PMID: 17917554 DERIVED

Related Links

• Nathan S Kline Institute for Psychiatric Research

MeSH Terms

Conditions

Schizophrenia; Impulsive Behavior; Aggression

Interventions

Risperidone; Valproic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Social Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Leslie L Citrome, MD, MPH

  Nathan S Kline Institute for Psychiatric Research and New York University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jan Volavka, MD, PhD

  Nathan S Kline Institute for Psychiatric Research and New York University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 29, 2006
• Study Start: September 1, 1999
• Study Completion: April 1, 2004
• Last Updated: March 29, 2006

Record last verified: 2006-03

Locations

US (1)