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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00454883
First received: March 29, 2007
Last updated: November 18, 2008
Last verified: November 2008
History of Changes

March 29, 2007
November 18, 2008
April 2007
December 2007   (final data collection date for primary outcome measure)
  • Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Recording of extrapyramidal symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Changes in manic symptoms over course of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00454883 on ClinicalTrials.gov Archive Site
  • Severity of disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00454883
A1281159
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2008

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