Status:
COMPLETED
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
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 qu...
Detailed Description
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
753 Patients enrolled
Trial Details
Trial ID
NCT00216476
Start Date
October 1 2004
End Date
November 1 2007
Last Update
April 16 2014
Active Locations (96)
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1
Hall in Tirol, Austria
2
Linz, Austria
3
Neunkirchen, Austria
4
Pleven, Bulgaria