Status:
COMPLETED
A Study Comparing the Efficacy of Long-acting Injectable Risperidone and Olanzapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to document both short-term, as well as long-term efficacy and safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine for the treatme...
Detailed Description
Many schizophrenia patients currently take oral antipsychotic medications daily, but long-acting injectable formulations may eliminate this need for the daily medication. This is an open-label study o...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
- Positive and Negative Syndrome Scale (PANSS) total score =\>50, indicating at least a minimum level of mental and behavioral disorders
- Recent hospitalization or an episode of psychosis requiring medical intervention
- Body Mass Index (BMI) \<=40 (BMI \>=30 indicates obesity)
Exclusion
- Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
- History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- Past treatment with clozapine
- Pregnant or nursing females, or those lacking adequate contraception
- Known sensitivity or unresponsiveness to risperidone or olanzapine
- Treatment with a long-acting injectable antipsychotic drug near the time of the trial start
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00236457
Start Date
November 1 2000
End Date
December 1 2002
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.