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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

March 21, 2008
March 27, 2008
April 10, 2008
August 2003
Not Provided
Change from baseline in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Until Final Visit (within 3 months) ]
Same as current
Complete list of historical versions of study NCT00645320 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: Baseline and Months 1, 2, and 3 ]
Same as current
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pyschotic Disorders
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
Experimental: A
Intervention: Drug: Ziprasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Same as current
August 2004
Not Provided

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.)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00645320
A1281114
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP