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Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

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NCT00454883

Last updated on April 10, 2018
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Affective Psychosis, Mania, Manic-Depressive Psychosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Manic and mixed episodes of up to moderate severity in patients with Type I and II
bipolar disorder and schizoaffective disorder; either first diagnosed or repeated
episodes

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

- Hypersensitivity to ziprasidone

- prolonged QTc interval

- coadministration with substances that are prolonging the QTc interval

- recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or
III medicaments

NCT00454883
Pfizer
Completed
Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

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Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)
  • Affective Psychosis, Bipolar
  • Mania
  • Manic-Depressive Psychosis
Drug: ziprasidone
Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
Other Name: Geodon, Zeldox
1 cohort of patients treated with ziprasidone
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
379
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes

Exclusion Criteria:

  • Hypersensitivity to ziprasidone
  • prolonged QTc interval
  • coadministration with substances that are prolonging the QTc interval
  • recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Slovakia
 
NCT00454883
A1281159
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

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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Contact

[email protected]



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