A Study to Assess Safety and Tolerabiltiy Associated With a Switch From Oral Antipsychotic Medications to Long-acting Injectable Risperidone in Patients With Schizophrenia.
The primary purpose of the study is to assess the safety and tolerability of a long-acting injectable formulation of risperidone when switching from an oral antipsychotic in patients with schizophrenia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Trial Exploring A Switching Regimen From Oral Neuroleptics, Other Than Risperidone, To Risperidone Depot Microspheres|
- Incidence, type, and severity of treatment-emergent adverse events throughout the treatment period.
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) at end of treatment period (Week 12); Extrapyramidal Symptom Rating Scale
|Study Start Date:||August 2001|
|Study Completion Date:||October 2002|
For schizophrenia patients taking oral antipsychotic medications, a long-acting injectable formulation of a antipsychotic medication may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This is an open-label, non-randomized study of a formulation of risperidone (coated microspheres) injected into the muscle at 2 week intervals over 12 weeks in patients with schizophrenia. The study has two phases: during the first 4 weeks, patients continue treatment with their present medication (haloperidol, quetiapine fumarate, or olanzapine); during the second phase of 12 weeks, patients receive the injectable formulation of risperidone, while continuing to receive their present medication for 3 weeks until the risperidone long-acting injectable reaches effective drug levels. For the remainder of the 12-week treatment phase, patients receive only injectable risperidone every 2 weeks. Safety evaluations include the incidence, type, and severity of treatment-emergent adverse events throughout the study; vital signs (pulse, blood pressure), clinical laboratory tests (hematology, biochemistry, urinalysis), electrocardiograms (ECGs), and extrapyramidial symptoms are also monitored at specified intervals. Assessments of effectiveness include the Positive and Negative Syndrome Scale (PANSS) and overall severity of illness measured by the Clinical Global Impression (CGI) scale. The study hypothesis is that long-acting injectible risperidone will be well-tolerated in the treatment of patients with schizophrenia after switching from treatment with an oral antipsychotic. Risperidone injections (25 milligrams[mg]) every 2 weeks for 12 weeks. Investigator may adjust dosage to 37.5mg or 50 mg (maximum) or supplement risperidone injections with risperidone tablets (1mg), according to symptoms and treatment response.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|