A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.
|ClinicalTrials.gov Identifier: NCT00558298|
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||811 participants|
|Masking:||None (Open Label)|
|Official Title:||Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder - an Open Label Follow up Trial of RIS-INT-57 and RIS-INT-61.|
|Study Start Date :||February 2000|
|Study Completion Date :||February 2005|
- To document the long-term safety of 25, 50 and 75 mg long-acting injectable risperidone from baseline until study endpoint.
- The mean values and change from baseline in Clinical Global Impression scale (CGI) at each time point until study endpoint.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558298
|Study Director:||Janssen, LP Clinical Trial||Janssen, LP|