Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
NCT00454883
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders. | |||
| Official Title | Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder | |||
| Brief Summary | Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders. | |||
| Detailed Description | 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals) | |||
| Condition |
| |||
| Intervention | 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 | |||
| Study Groups/Cohorts | 1 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 Status | Completed | |||
| Actual Enrollment | 379 | |||
| Original Enrollment | 420 | |||
| Actual Study Completion Date | December 2007 | |||
| Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | Slovakia | |||
| Administrative Information | ||||
| NCT Number | NCT00454883 | |||
| Other Study ID Numbers | A1281159 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2021 | |||