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.