A Long-term Safety Study for Long-acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients.
|ClinicalTrials.gov Identifier: NCT00495118|
Recruitment Status : Completed
First Posted : July 2, 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 :||314 participants|
|Intervention Model:||Single Group Assignment|
|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-62 and RIS-INT-85.|
|Study Start Date :||October 2001|
|Actual Study Completion Date :||March 2005|
- To document the long-term safety of 25, 37.5 and 50 mg long-acting injectable risperidone from baseline until study end point.
- To document long-term efficacy by measuring mean values and clinical improvement in Positive and Negative Symptoms Scale (Visits 3 & 5 to 10), and Clinical Global Impression scale (Visits 2 to 10), compared with previous and extension baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495118
|Study Director:||Janssen, LP Clinical Trial||Janssen, LP|