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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00132314 |
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectible risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.
Condition | Intervention | Phase |
---|---|---|
Schizoaffective Disorder Schizophrenia |
Drug: IM risperidone Drug: oral antipsychotic medication |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia |
Estimated Enrollment: | 450 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
long-acting injectable risperidone
|
Drug: IM risperidone
long-acting injectable risperidone
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2: Active Comparator
oral antipsychotic medication
|
Drug: oral antipsychotic medication
doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
|
The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication adherence, side effects, and health care costs.
Objectives:
Primary: To evaluate the impact of long-acting intramuscular (IM) risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years.
Secondary: To evaluate adherence, health benefits, and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by: a) symptom reduction over 12 months, b) time to all-cause medication discontinuation, c) quality of life, d) VA and non-VA health service use and related costs, e) medication side effects, f) violent behavior, g) use of concomitant medication, and h) the incremental cost-effectiveness ratio.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients should
The b criterion will promptly be adjudicated by the study chairmen on a case-by case basis to insure credibility.
Exclusion Criteria:
Study Chair: | Robert A. Rosenheck, AB MD | VA Connecticut Health Care System (West Haven) |
Responsible Party: | Department of Veterans Affairs ( Rosenheck, Robert - Study Chair ) |
Study ID Numbers: | 555 |
Study First Received: | August 17, 2005 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00132314 History of Changes |
Health Authority: | United States: Federal Government |
Neurotransmitter Agents Tranquilizing Agents Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin |
Schizophrenia Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Risperidone Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions |
Schizophrenia Serotonin Antagonists Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Psychotic Disorders Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |