Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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. Howeve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00297388
End Date
September 1 2004
Last Update
May 18 2011
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