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Sponsored by: |
Janssen, LP |
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Information provided by: | Janssen, LP |
ClinicalTrials.gov Identifier: | NCT00378183 |
The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the second phase of this study, investigators will assess the effectiveness of behavioral therapy in reducing body weight in risperdone-treated patients who are overweight or have problems with diabetes or blood sugar.
Condition | Intervention | Phase |
---|---|---|
Schizoaffective Disorder Schizophrenia |
Drug: risperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Open-Label, Rater Blinded Assessment of Optimal Treatment Change Strategy to Risperidone for Patients Intolerant of Olanzapine |
Enrollment: | 120 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR012520 |
Study First Received: | September 15, 2006 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00378183 History of Changes |
Health Authority: | United States: Institutional Review Board |
weight loss behavioral therapy risperidone switching antipsychotics schizoaffective disorder |
Risperdal schizophrenia olanzapine Zyprexa |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Olanzapine Risperidone Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin |
Body Weight Schizophrenia Dopamine Mental Disorders Weight Loss Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Schizophrenia Serotonin Antagonists Pathologic Processes Mental Disorders Therapeutic Uses Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Disease Tranquilizing Agents Gastrointestinal Agents Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |