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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308360
First Posted: March 29, 2006
Last Update Posted: March 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Janssen, LP
Research Foundation for Mental Hygiene, Inc.
Information provided by:
Nathan Kline Institute for Psychiatric Research
  Purpose
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.

Condition Intervention Phase
Schizophrenia Drug: Risperidone, divalproex Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility

Resource links provided by NLM:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Buss-Durkee Hostility Inventory
  • Barratt Impulsiveness Scale

Secondary Outcome Measures:
  • Overt Aggression Scale
  • Positive and Negative Syndrome Scale

Estimated Enrollment: 46
Study Start Date: September 1999
Estimated Study Completion Date: April 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) 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.

Exclusion Criteria:

1) Receiving both adequate amounts of valproate and risperidone at the time the inclusion criteria have been met. This was defined as a dose of valproate that was equal to or exceeding 1000 mg/day (or a plasma level equal to or greater than 50 micrograms/mL) for at least 2 weeks, and any dose of risperidone; 2) History of severe adverse reaction to either risperidone or valproate; 3) Administration of a slow-release antipsychotic (depot) within 30 days preceding randomization; and 4) Pregnancy.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308360


Locations
United States, New York
Nathan S Kline Institute for Psychiatric Research and Rockland Psychiatric Center, Clinical Research and Evaluation Facility
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Janssen, LP
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00308360     History of Changes
Other Study ID Numbers: RIS-189
First Submitted: March 28, 2006
First Posted: March 29, 2006
Last Update Posted: March 29, 2006
Last Verified: March 2006

Keywords provided by Nathan Kline Institute for Psychiatric Research:
Hostility
Impulsivity
Aggression

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Valproic Acid
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents