Phase 4
Completed N=355
Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00299702 ↗Enrolled (actual)
355
Serious AEs
18.6%
Results posted
Mar 2010
Primary outcomePrimary: Time to Relapse — 131; 113 days — p=0.684
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 patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse |
131; 113 | 0.684 |
| PRIMARY Time in Remission |
373.5; 356.7 | 0.646 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00299702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.