A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to document the long-term safety and tolerability of risperidone, formulated as a long-acting injectable, in the treatment of patients with schizophrenia or schizoaffective disorder; in addition, to evaluate the long-term effectiveness of long-acting risperidone and its effect on quality of life
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder|
- Incidence of adverse events; Injection site evaluation; Extrapyramidal Sympton Rating Scale (ESRS) results at each visit for at least 1 year; Clinical evaluations (physical exams, laboratory tests) will be conducted throughout trial
- Clinical Global Impression Severity of illness subscale (CGI-Severity) at each visit for at least 1 year. SF-36 assessed yearly.
|Study Start Date:||December 1999|
|Study Completion Date:||February 2004|
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This safety study is an extension of a randomized, double-blind, multicenter, parallel group study that investigates effectiveness and safety of risperidone injected intramuscularly in patients with schizophrenia or schizoaffective disorder. The present open-label study evaluates 3 different doses of a formulation of risperidone injected into the muscle at 2 week intervals for at least 1 year in patients with these conditions. Assessments of effectiveness include the Clinical Global Impression (CGI) overall severity of illness scale. Quality of life will be assessed by the SF-36 Health Survey. Safety evaluations include incidence of adverse events, physical examinations, and evaluations of the injection site, clinical laboratory tests, electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale assessing muscle tone, gain, and abnormal movements. Injections every 2 weeks for at least 1 year, beginning at 25milligrams[mg] and increasing to 50mg or 75mg (maximum dose). Dosages may be increased or decreased at investigator's discretion. During the first 3 weeks, risperidone tablets (2mg) once daily to supplement injectable risperidone.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|