Status:
COMPLETED
A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Schizophrenia
Eligibility:
All Genders
16-45 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis
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
- Meet the criteria of the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis
- patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication
- patients who will require at least 12 months of treatment
Exclusion
- DSM-IV axis I diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder
- patients requiring treatment with mood stabilizers or antidepressants at study initiation
- alcohol or drug abuse or dependence, according to DSM-IV criteria
- history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- previous treatment with an injectable antipsychotic medication
- pregnant or nursing females, or those lacking adequate contraception
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00216580
Start Date
February 1 2004
End Date
December 1 2006
Last Update
March 25 2013
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