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A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study

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ClinicalTrials.gov Identifier: NCT00645320
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol A1281074).

Condition or disease Intervention/treatment Phase
Pyschotic Disorders Drug: Ziprasidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone
Study Start Date : August 2003
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Drug: Ziprasidone
Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
Other Name: Geodon, Zeldox




Primary Outcome Measures :
  1. Change from baseline in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Until Final Visit (within 3 months) ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Baseline and Months 1, 2, and 3 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Psychotic disorder
  • Completion of previous study of intramuscular ziprasidone
  • Ability to continue with oral ziprasidone

Exclusion Criteria:

  • Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment.
  • Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks.
  • Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645320


Locations
Brazil
Pfizer Investigational Site
Salvador, Bahia, Brazil, 41180-000
Pfizer Investigational Site
Fortaleza, Ceara, Brazil, 60175-270
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-270
Pfizer Investigational Site
Curitiba, PR, Brazil
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site
Jardim Santa Monica Sn, Salvador - Ba, Brazil, 40340-720
Pfizer Investigational Site
Sao Paulo, SP, Brazil
Pfizer Investigational Site
Rio de Janeiro Rj, Brazil, 22640-100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645320     History of Changes
Other Study ID Numbers: A1281114
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents