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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salvador, Bahia, 41180-000 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pyschotic Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Psychotic disorder

- Completion of previous study of intramuscular ziprasidone

- Ability to continue with oral ziprasidone

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.)

NCT00645320
Pfizer
Completed
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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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
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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