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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 November 13, 2019
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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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Descriptive Information
Brief TitleNon-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
Official TitleTreatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
Brief SummaryAssessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
Detailed DescriptionMethod: 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.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)
Condition
  • Affective Psychosis, Bipolar
  • Mania
  • Manic-Depressive Psychosis
InterventionDrug: 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
Study Groups/Cohorts1 cohort of patients treated with ziprasidone
Intervention: Drug: ziprasidone
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: January 4, 2008)		379
Original Enrollment
 (submitted: March 30, 2007)		420
Actual Study Completion DateDecember 2007
Actual Primary Completion DateDecember 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location CountriesSlovakia
 
Administrative Information
NCT NumberNCT00454883
Other Study ID NumbersA1281159
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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