Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

Launched by JANSSEN PHARMACEUTICA N.V., BELGIUM · Sep 14, 2005

Keywords

ClinConnect Summary

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 regiment. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. Traditionally, patients experiencing an episode of schizophrenia are first treated with oral medications until they are stabilized, and then injectable long-acting formulations are given. This is an open, multicenter, randomized Phase IV trial in patients after an acute episode of ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)
• • acute episode of schizophrenia within 2 weeks of study entry
• • o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
• • Positive And Negative Syndrome Scale (PANSS) score \>=80
• • Clinical Global Impression - Severity (CGI-S) score \>=5
• Exclusion Criteria:
• • DSM-IV axis I diagnosis other than schizophrenia
• • known hypersensitivity or lack of response to risperidone
• • pregnant or nursing females, or those without adequate contraception
• • alcohol or drug abuse or dependence diagnosed in the last month prior to entry,