A Study of Long-Acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Risperidone (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Official title: Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: 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
Secondary outcome: Clinical Global Impression Severity of illness subscale (CGI-Severity) at each visit for at least 1 year. SF-36 assessed yearly.
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Patients must have completed the double-blind study (RIS-USA-121) or withdrawn from that
study for safety reasons or due to worsening of condition as determined by results from the
Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic
and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
Otherwise healthy on the basis of physical examination, medical history, electrocardiogram,
blood biochemistry and hematology tests, and urinalysis
Known intolerance, sensitivity, serious adverse events, or unresponsiveness to
Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective
Diagnosis of substance abuse or dependence
Use of psychostimulants or an antipsychotic medication other than risperidone
Known disease of the central nervous system (stroke, Parkinson's Disease, Huntington's
Disease, Alzheimer's Disease, cancer)
Pregnant or nursing females, or those lacking adequate contraception
Locations and Contacts
Starting date: October 1999
Ending date: February 2004
Last updated: October 16, 2007