Phase 3
N=711
A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Schizophrenia · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00216476 ↗Enrolled (actual)
711
Serious AEs
20.7%
Results posted
Aug 2010
Primary outcome: Primary: Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) — 607; 533 days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug); Risperidone Long Acting Injectable (LAI) (Drug); Quetiapine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag International NV
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) |
607; 533 | <0.0001 sig |
| SECONDARY Mean Relapse Free Period (Exploratory/Aripiprazole) |
314 | — |
| SECONDARY Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score |
-9.3; -1.1; -7.7 | <0.0001 sig |
| SECONDARY Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score |
-0.3; 0.1; -0.1 | <0.0001 sig |
| SECONDARY Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores |
2.1; 1.0; 2.4; 3.2; 2.7; 4.9 | 0.0941 |
Summary
The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- Patients currently treated with oral risperidone, olanzapine or a conventional neuroleptic monotherapy at doses not exceeding 6 mg risperdal, 20 mg olanzapine, or a conversion dose of 10 mg haloperidol for oral conventional agents
- Patients who are stable (judged clinically stable by the investigator and on a stable dose of medication for 4 weeks or longer) but not optimally treated (non-satisfactory treatment regarding symptoms or adverse events)
Exclusion Criteria
- Diagnosis other than schizophrenia or schizoaffective disorder by DSM-IV Axis I criteria
- Patients being treated with antipsychotic agents other than oral risperidone, olanzapine or conventional oral neuroleptic agents
- Patients with known hypersensitivity to oral risperidone, quetiapine, aripiprazole, or who are known non-responders to oral risperidone, quetiapine, aripiprazole or to previous treatment with at least 2 antipsychotic agents
- Patients treated with mood stabilizers or antidepressants who are not on stable dose for at least 3 months before study initiation
- Pregnant or nursing females, or those lacking adequate contraception
Data sourced from ClinicalTrials.gov (NCT00216476). 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.