A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-Acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizoaffective Disorder; Schizophrenia
Intervention: Risperidone, long-acting injectable (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 assess the time for patients to relapse when switched from an
oral antipsychotic to one of two doses of long-acting risperidone injection (shots).
Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.
Official title: A 52-wk Prospective, Randomized, Double-Blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-Acting Microspheres (Risperdal® CONSTA®) in Adults With Schizophrenia or Schizoaffective Disorder
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Primary outcome: Risperidone effectiveness is measured by time to relapse within the 52 week period.
Secondary outcome: Effectiveness of the drug is assessed by the Clinical Global Impression Scale and Positive and Negative Syndrome Scale; safety as assessed by the Extrapyramidal Symptom Rating Scale and treatment-emergent adverse events during the 52 week period.
Results from studies of older long-acting injectable antipsychotics (not risperidone) show
that patients tend to relapse (which means start having symptoms again) when they are given
low doses. However, increasing the dose may cause more side effects. This study will measure
the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective
disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses
of long-acting risperidone injections (shots). The patients will be assigned to a dose of
either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual
oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week
period, they will receive the injectable risperidone only. Patients will be asked questions
at each visit to help determine the effectiveness of the drug as assessed by the Clinical
Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug
will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom
Rating Scale and self-reported treatment-emergent adverse events.
Long-acting risperidone injection, 25 or 50 milligrams per injection, every 2 weeks for 52
weeks. Patients will continue to take their current oral antipsychotics for up to 3 weeks
following the first injection of risperidone.
Minimum age: 18 Years.
Maximum age: 70 Years.
- Patients diagnosed with schizophrenia or schizoaffective disorder
- Stable with respect to disease symptoms and other medical conditions
- Stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study
- Patients identify a relative or acquaintance who can complete a questionnaire with
additional information about the patient
- If female, using birth control
- Patient is not eligible if currently hospitalized, or was treated for an acute
disease-related crisis within the past 4 weeks
- At risk to self or others
- Use of injectable antipsychotic drugs or electroconvulsive therapy within past 6
months, or currently using carbamazepineor an oral antipsychotic drug in a dose that
is higher than 8 milligrams per day in risperidone equivalents, of long-acting
risperidone in an earlier study, of clozapine, or use of investigational drugs within
30 days, or of electroconvulsive therapy within past 6 months
- Presence of liver or kidney damage
- History of neuroleptic malignant syndrome
- If pregnant or breast-feeding
- Not using birth control
- Abusing drugs or alcohol
Locations and Contacts
A 52-week, prospective, randomized, double-blind, multicenter study of relapse following transition from oral antipsychotic medication to two different doses of risperidone long-acting microspheres in adults with schizophrenia or schizoaffective disorder
Ending date: September 2004
Last updated: March 31, 2008