A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study
An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone
1 other identifier
interventional
75
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2003
Shorter than P25 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedFebruary 21, 2021
February 1, 2021
March 21, 2008
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Clinical Global Impression-Severity (CGI-S) score
Until Final Visit (within 3 months)
Secondary Outcomes (1)
Adverse events
Baseline and Months 1, 2, and 3
Study Arms (1)
A
EXPERIMENTALInterventions
Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
Eligibility Criteria
You may qualify if:
- Psychotic disorder
- Completion of previous study of intramuscular ziprasidone
- Ability to continue with oral ziprasidone
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Pfizer Investigational Site
RIO de Janeiro RJ, Brazil, 22640-100, Brazil
Pfizer Investigational Site
Fortaleza, Ceará, 60175-270, Brazil
Pfizer Investigational Site
Salvador, Estado de Bahia, 41180-000, Brazil
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30150-270, Brazil
Pfizer Investigational Site
Curitiba, Paraná, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
Jardim Santa Monica SN, Salvador - BA, 40340-720, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 27, 2008
Study Start
August 1, 2003
Study Completion
August 1, 2004
Last Updated
February 21, 2021
Record last verified: 2021-02