Status:
COMPLETED
Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effectiveness of two antipsychotic medications, Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term maintenance of patien...
Detailed Description
Although many patients with schizophrenia currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectab...
Eligibility Criteria
Inclusion
- Patients with diagnosis of schizophrenia
- Patient has had at least 2 psychotic relapses in the two years prior to study entry
- patient is not adequately benefiting from their current antipsychotic medication
Exclusion
- Patients that have been hospitalized or had major medication changes within 2 months of study entry
- Patients currently experiencing, or who have experienced worsening of disease symptoms within 2 months of study entry
- Patients currently using clozapine or carbamazepine
- Patients who have undergone electroconvulsive therapy or depot antipsychotic treatment within 6 months prior to study entry
- pregnant or breast-feeding
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00299702
Start Date
February 1 2006
End Date
January 1 2009
Last Update
December 30 2011
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