Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, intramuscular injection, antipsychotic agents, long-acting risperidone
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,
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
001
002
early initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
routine initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.