A Study of Risperidone Long-acting Injection Versus Oral Antipsychotics in Schizophrenia Patients With a History of Being Poorly Compliant With Taking Their Medication

• The proportion of subjects experiencing a clinical intensification of schizophrenia symptoms after being in the study for 3 months. [ Time Frame: 24 months post-randomization ] [ Designated as safety issue: No ]
  

• PANSS, CGI-S and CGI-C, RUQ, AQoL, PSP, evaluation of symptomatic remission over time, proportion of clinical intensification of symptoms during the trial, time to intensification of symptoms and the number of incidences of intensification of symptoms [ Time Frame: 24 months post-randomization ] [ Designated as safety issue: Yes ]
  

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 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.

Addendum: In the sentence starting "Oral supplementation with the current…" the words "or conventional neuroleptic" were removed. The latest version of the protocol (amendment #2) does not allow for the use of conventional neuroleptics as oral supplementation. 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 is required for the first 3 weeks following the initial injection and dose increases.

Addendum: removed conventional neuroleptic. See 4b for details.