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Sponsors and Collaborators: |
Solvay Pharmaceuticals H. Lundbeck A/S Wyeth |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00347425 |
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
Condition | Intervention | Phase |
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Schizophrenia and Schizoaffective Disorder |
Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone Drug: Quetiapine Drug: Ziprasidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder |
Enrollment: | 286 |
Study Start Date: | December 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A |
Drug: Aripiprazole
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Olanzapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Risperidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Quetiapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Ziprasidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
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B |
Drug: Aripiprazole
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Olanzapine
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Risperidone
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Quetiapine
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Ziprasidone
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Loretta Stallings ) |
Study ID Numbers: | S154.3.020, 2006-004972-11 |
Study First Received: | June 30, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00347425 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health |
Switch Study Schizophrenia Atypical Antipsychotics |
Neurotransmitter Agents Tranquilizing Agents Olanzapine Risperidone Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin |
Schizophrenia Quetiapine Dopamine Mental Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Aripiprazole Ziprasidone Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Schizophrenia Serotonin Antagonists Pathologic Processes Mental Disorders Therapeutic Uses Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Disease Gastrointestinal Agents Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Quetiapine Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Ziprasidone |