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Sponsored by: |
Janssen-Ortho Inc., Canada |
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Information provided by: | Janssen-Ortho Inc., Canada |
ClinicalTrials.gov Identifier: | NCT00256997 |
The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia patients with a history of being poorly compliant with taking their medication.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: risperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pragmatic Randomized Trial of Risperdal® CONSTA® (Risperidone) Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting. |
Estimated Enrollment: | 260 |
Study Start Date: | December 2005 |
This is a randomized, open-label, parallel group, multi-country and multi-centre study of Risperdal long-acting formulation versus oral atypical antipsychotics in subjects with a DSM-IV TR diagnosis of schizophrenia currently being treated with oral antipsychotic medication. The primary objective of this trial is to determine whether Risperdal long-acting formulation provides improved effectiveness over a 2-year period, measured by the proportion of subjects who experience a clinical exacerbation, as compared to oral atypical antipsychotics prescribed in a routine care setting for the treatment of subjects with schizophrenia. Subjects will be randomized to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole and amisulpride) or to Risperdal long-acting formulation. For Risperdal long-acting formulation subjects, study medication will be administered by intramuscular injection every 2 weeks at doses of 25, 37.5 or 50 mg. Oral supplementation with the current oral atypical antipsychotic or conventional neuroleptic is required for the first 3 weeks following the initial injection and dose increases. Dose increases can be made as per product labeling. The primary measure of effectiveness is the reduction in the proportion of subjects experiencing a clinical exacerbation after being in the study for 3 months. Additional measures of effectiveness include: symptom improvement on the Positive and Negative Syndrome Scale for schizophrenia (PANSS) and Clinical Global Impression (CGI) - S/C; use of health care resources as assessed by Resource Utilization Questionnaire (RUQ) and changes in quality of life, assessed using Assessment of Quality of Life (AQoL) questionnaire; time to first clinical exacerbation; the number of clinical exacerbations calculated at 2 time points: occurring 12 weeks post-randomization and the entire trial duration; the proportion of clinical exacerbations for the entire trial period; the evaluation of symptomatic remission over time; and the Personal and Social Performance Scale (PSP). Safety assessments include the incidence of adverse events throughout the study, AIMS, laboratory tests, vital signs, weight, waist and hip circumference and physical examination.
Oral atypical antipsychotic (risperidone, olanzapine, quetiapine, aripiprazole or amisulpride, dosage according to product labeling) or risperidone, long-acting formulation (25, 37.5 or 50 mg) administered by intramuscular injection every 2 weeks, for the 2-year study. Oral supplementation with the current oral atypical antipsychotic or conventional neuroleptic is required for the first 3 weeks following the initial injection and dose increases.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Janssen-Ortho Inc. Clinical Trial | Janssen-Ortho Inc., Canada |
Study ID Numbers: | CR006016 |
Study First Received: | November 18, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00256997 |
Health Authority: | United States: Institutional Review Board |
Schizophrenia long-acting injectable atypical antipsychotic Risperidone compliance |
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders 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 |