Non-Interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
Affective Psychosis, Bipolar
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder|
- 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 ]
- Severity of disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|1 cohort of patients treated with 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454883
|Study Director:||Pfizer CT.gov Call Center||Pfizer|