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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00406315 |
The primary objective of this study is to evaluate change in weight as a result of switching to ziprasidone, in schizophrenic subjects who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
Condition | Intervention | Phase |
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Schizophrenia or Schizoaffective Disorder |
Drug: ziprasidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder |
Estimated Enrollment: | 250 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1
atypical antipsychotic for the treatment of schizophrenia
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Drug: ziprasidone
Days 1-3: 40 mg BID; Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A1281148 |
Study First Received: | November 29, 2006 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00406315 |
Health Authority: | United States: Food and Drug Administration |
ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder |
Schizophrenia Quetiapine Dopamine Mental Disorders |
Psychotic Disorders Ziprasidone Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |