|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Nathan Kline Institute for Psychiatric Research Janssen, LP Research Foundation for Mental Hygiene |
|---|---|
| Information provided by: | Nathan Kline Institute for Psychiatric Research |
| ClinicalTrials.gov Identifier: | NCT00308360 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility |
| Estimated Enrollment: | 46 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | April 2004 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| 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
| Study ID Numbers: | RIS-189, RIS-189 |
| Study First Received: | March 28, 2006 |
| Last Updated: | March 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00308360 |
| Health Authority: | United States: Food and Drug Administration |
|
Hostility Impulsivity Aggression |
|
Schizophrenia Dopamine Mental Disorders Risperidone Psychotic Disorders |
Aggression Valproic Acid Serotonin Schizophrenia and Disorders with Psychotic Features |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |
