Official Title: “Pragmatic Randomized Trial of Risperdal® CONSTA® (Risperidone) Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: risperidone

Primary Measures

• The proportion of subjects experiencing a clinical intensification of schizophrenia symptoms after being in the study for 3 months.

Secondary Measures

• 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

Inclusion Criteria:

• Diagnosis of schizophrenia as per DSM-IV
• Have had at least 2 hospitalizations or 2 clinical worsening of symptoms over the past 2 years due the patient suspected of being poorly compliant with taking their medication
• Is currently receiving treatment with an antipsychotic per local labeling, and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine)
• Otherwise healthy, as confirmed by physical exam, vital signs, and laboratory testing: female subjects must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening before study entry

Exclusion Criteria:

• Subjects with a primary DSM-IV TR Axis I diagnosis other than schizophrenia
• Previously treated or currently on clozapine
• Have a serious, unstable and untreated medical illnesses, such as vascular or cardiovascular disease, history of liver or kidney disease, significant cardiac, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances
• At significant risk of suicide or violence at study start
• Evidence of alcohol or medication abuse or dependence

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen-Ortho Inc., Canada

Overall Clinical Trial Officials and Contacts

Janssen-Ortho Inc. Clinical Trial Study Director Janssen-Ortho Inc., Canada  

Overall 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

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00256997

Study ID Number: CR006016

ClinicalTrials.gov Identifier: NCT00256997

Health Authority: United States: Institutional Review Board

To learn how to participate in this trial please click here.