A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Open-Label, Rater Blinded Assessment of Optimal Treatment Change Strategy to Risperidone for Patients Intolerant of Olanzapine|
- The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.
- The change from baseline in Client Satisfaction Questionnaire (CSQ-8) score at week 14 of Phase 2 and the change from baseline in Global Assessment of Functioning (GAF) score at week 14 of Phase 2.
|Study Start Date:||February 2001|
|Study Completion Date:||May 2002|
Data regarding the safety and effectiveness of different strategies for switching subjects with schizophrenia from one antipsychotic medication to another are very rare. Studies that have examined various switching designs, especially with regard to the newer atypical antipsychotic agents, suggest that either abrupt or gradual discontinuation does not inevitably lead to worsening of symptoms. This study is randomized (patients are assigned different treatments based on chance), open-label, with a parallel group design to assess the safety and effectiveness of each of three strategies of discontinuing olanzapine and starting risperidone. The first strategy is the discontinuation of olanzapine on the day risperidone is started. The second strategy involves a reduction in the dose of olanzapine to one half of the study entry dose on the day risperidone is started. The reduced dose of olanzapine is to be given for one week and then discontinued. In the third strategy, the dose of olanzapine remains unchanged for the first week, then is reduced by one half of the study entry dose, and at the end of the second week is discontinued. In all three strategies, patients take the same dose of risperidone: 1 mg by mouth twice a day for 3 days, then 2 mg twice a day for the next 4 days. Further increase or decrease of risperidone dose and/or changing to a single daily dose can be carried out at the end of the first week. Additionally, after 6 weeks of risperidone therapy, patients who are overweight or have problems with diabetes or blood sugar may enter a second phase of the study that examines weight loss. In this phase, patients are randomized to receive routine clinical care or training on weight management behavioral techniques while continuing to take risperidone for an additional 14 weeks. At the end of 14 weeks, total weight loss, changes in lipids, cholesterol and other laboratory measures will be compared between the two groups. The study hypothesis is that symptom improvement or worsening at week 14, as measured by total score on the Positive and Negative Syndrome Scale (PANSS), should not differ depending on the method of switching from olanzapine to risperidone. Safety evaluations incude collection of adverse events, clinical laboratory tests and assessment of vital signs.
The patients will receive oral tablets of risperidone 1 to 2 milligram[mg] twice a day (higher or lower dose and/or changing to single daily dose allowed at end of the first week) for the duration of 6 weeks in phase 1, and then for 14 more weeks in phase 2 of the study. Olanzapine: none; or half of the study entry dose for 1 week; or study entry dose for 1 week, then half of the study entry dose for an additional week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378183
|Study Director:||Janssen, LP Clinical Trial||Janssen, LP|