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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 |
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 |
Schizophrenia Quetiapine Dopamine Mental Disorders Risperidone Olanzapine |
Psychotic Disorders Aripiprazole Ziprasidone Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |