Affective Psychosis, Bipolar, Mania, Manic-Depressive Psychosis
Conditions
Keywords
Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, 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.
Interventions
DRUGziprasidone
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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical global impression | 3 months |
| Recording of extrapyramidal symptoms | 3 months |
| Changes in manic symptoms over course of treatment | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Severity of disease | 3 months |
| Adverse Events | 3 months |
Outcome results
None listed