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Sponsors and Collaborators: |
Massachusetts General Hospital Pfizer |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00403546 |
The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 mg/d compared to continued standard treatment (placebo) as measured by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes Akathisia Scale (BAS), serum prolactin concentrations, vital signs, EKG and completion rates and to assess whether ziprasidone dose escalation improves overall psychopathology compared to continued standard treatment as measured by the change from baseline in PANSS total score and response rates as defined by a 20% or greater reduction in PANSS total score.
The secondary aims of this study are to assess whether ziprasidone dose escalation improves psychotic symptoms compared to continued standard treatment as measured by the Positive Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms compared to continued standard treatment as measured by the Calgary Depression Rating Scale (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with the CGI-S, CGI-I, GAF and the Schizophrenia Cognition Rating Scale (SCoRS).
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Geodon |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High-Dose Oral Ziprasidone Versus Conventional Dosing in Schizophrenia Patients With Residual Symptoms |
Estimated Enrollment: | 80 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Raeke, M.A. | 617-912-7840 | lraeke@partners.org |
Contact: Kelsey Shannahan, B.A. | 617-912-7868 | kshannahan@partners.org |
United States, Georgia | |
Medical College of Georgia | Recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Edna Stirewalt 706-721-7968 estirewalt@mcg.edu | |
Contact: Rebecca Blizard 706-721-4605 RBLIZARD@mail.mcg.edu | |
Principal Investigator: Peter Buckley, M.D. | |
United States, Massachusetts | |
Corrigan Mental Health Center | Recruiting |
Fall River, Massachusetts, United States, 02720 | |
Contact: Samantha Samberg 508-235-7343 ssamberg@bidmc.harvard.edu | |
Contact: Amanda Fennessey 508-235-7299 amanda.fennessey@dmh.state.ma.us | |
Principal Investigator: Theo Manschreck, M.D. | |
Sub-Investigator: Roger Boshes, M.D. | |
United States, Michigan | |
Touchstone innovare | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Heather Willett 616-459-4212 heatherw@TI-GR.com | |
Principal Investigator: Eric Achtyes, M.D. | |
United States, New Mexico | |
University of New Mexico | Recruiting |
Albuquerque, New Mexico, United States, 87131 | |
Contact: Tara Biehl 505-272-9544 TBiehl@salud.unm.edu | |
Principal Investigator: Juan Bustillo, M.D. | |
United States, New York | |
Nathan Kline Institute | Recruiting |
Orangeburg, New York, United States, 10962 | |
Contact: Stephanie Kamiel 845-398-6567 skamiel@nki.rfmh.org | |
Principal Investigator: Leslie Citrome, M.D. | |
The Lieber Center for Schizophrenia Research - Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Beatriz Alvarez 212-543-5418 Alvarez@pi.cpmc.columbia.edu | |
Contact: Christine Woenne 212-543-5173 Woennec@pi.cpmc.columbia.edu | |
Principal Investigator: Roberto Gil, M.D. | |
SUNY Downstate Medical Center | Recruiting |
Brooklyn, New York, United States, 11203 | |
Contact: Veronika Stock 718-270-7266 Veronika.Stock@downstate.edu | |
Principal Investigator: Miranda Chakos, M.D. | |
United States, North Carolina | |
Duke University - John Umstead Hospital | Recruiting |
Butner, North Carolina, United States, 27509 | |
Contact: Jenny Thrall 919-575-7162 jenny.thrall@gmail.com | |
Principal Investigator: Joseph McEvoy, M.D. | |
Sub-Investigator: William Wilson, Ph.D. | |
United States, Texas | |
The Mech Center | Recruiting |
Plano, Texas, United States, 75024 | |
Contact: Ansar A Sheikh 972-265-3127 ext 150 thusikagramle@yahoo.com | |
Principal Investigator: Arnold Mech, M.D. |
Principal Investigator: | Donald Goff, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Donald Goff, MD ) |
Study ID Numbers: | 2005-P-001372 |
Study First Received: | November 21, 2006 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00403546 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Schizophrenia |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin Schizophrenia |
Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Ziprasidone Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions |
Schizophrenia Serotonin Antagonists Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Ziprasidone Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |