Status:
COMPLETED
Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Janssen, LP
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.
Detailed Description
Risperidone, taken by mouth on a daily basis, has been an effective treatment for schizophrenia and schizoaffective disorder. Risperidone is also available in a long-acting injectable form so that pat...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
- if female, using birth control.
Exclusion
- Hospitalized within 8 weeks of beginning the study
- at risk to self or others
- presence of liver or kidney damage
- use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
- pregnant or breast-feeding
- if female, not using birth control
- abusing drugs or alcohol.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00236353
Start Date
May 1 2002
End Date
December 1 2003
Last Update
May 17 2011
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