A Long-Term Safety Study for Long-Acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients.
Information source: Janssen, LP
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: risperidone (Drug)
Phase: Phase 3
Sponsored by: Janssen, LP
Official(s) and/or principal investigator(s):
Janssen, LP Clinical Trial, Study Director, Affiliation: Janssen, LP
The purpose of this study is to document the long-term safety of 25, 37. 5, or 50 mg
long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to
subjects with schizophrenia or schizoaffective disorder.
Official title: Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder - an Open-Label Follow-up Trial of RIS-INT-62 and RIS-INT-85.
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To document the long-term safety of 25, 37.5 and 50 mg long-acting injectable risperidone from baseline until study end point.
Noncompliance in taking medication is very common among people with schizophrenia, and is a
frequent cause of relapse of symptoms. A long-acting injectable formulation that ensures slow
but steady release of risperidone over a period of several weeks would eliminate the need to
take medication on a daily basis, and improve compliance. This is an open-label,
international, multicenter study in subjects with scizophrenia or schizoaffective disorder
who completed the risperidone microspheres arm of study RIS-INT-62, or who completed study
RIS-INT-85, or who dropped out of the risperidone microspheres arm of study RIS-INT-62 due to
treatment with 75 mg long-acting injectable risperidone. Patients have to begin this study
within 7 days of the final visit in the RIS-INT-62 or RIS-INT-85 studies. The end point visit
of the RIS-INT-62 or RIS-INT-85 study serves as the first visit of this open-label study.
Patients can start this study on the same dose as the last risperidone microsphere injection
that they received in the previous study, or at a dose that was 12. 5 mg lower or higher than
the previously received dose. Patients who received 75 mg risperidone microsphere injection
during study RIS-INT-62 can continue on this dose but an attempt will be made to decrease the
dose to 50 mg within 3 months. The total study duration is planned to be at least 1 year or
until approval of long-acting injectable risperidone in the respective country. The study
hypothesis is that treatment with the long-acting injectable formulation of risperidone every
2 weeks for at least 1 year will be safe and well tolerated, as assessed by adverse event
reporting, the extrapyramidal symptom rating scale, laboratory tests, vital signs
measurements, physical examinations, body weight measurements, electrocardiograms, and
injection site evaluations.
Patients will receive injections of risperidone depot microspheres (25, 37. 5, 50, or 75 mg)
in their gluteal muscle at 2-weekly intervals for at least 1 year.
Minimum age: 18 Years.
Maximum age: N/A.
- Diagnosis of schizophrenia (patients from RIS-INT-62 or RIS-INT-85) or schizoaffective
disorder (patients from RIS-INT-62 only) according to the Diagnostic and Statistical
Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- Patient completed the risperidone microspheres arm of RIS-INT-62, or completed
RIS-INT-85, or dropped out of the risperidone microspheres arm of RIS-INT-62 due to
treatment with 75 mg long-acting injectable risperidone
- Informed consent signed by the patient
- Patient is otherwise healthy on the basis of a prestudy physical examination and
- A DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder
- No pregnant or breast-feeding women
- No female patient of childbearing potential without adequate contraception
- No history of severe drug allergy or hypersensitivity
- No subjects known to be unresponsive to risperidone
Locations and Contacts
A long-term safety study for long-acting injectable risperidone in schizophrenia or schizoaffective disorder patients.
Starting date: October 2001
Ending date: March 2005
Last updated: January 31, 2008