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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.379 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

379

Conditions

Affective Psychosis, Bipolar Mania Manic-Depressive Psychosis

Interventions

ziprasidoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical global impression

Time frame: 3 months

Recording of extrapyramidal symptoms

Time frame: 3 months

Changes in manic symptoms over course of treatment

Time frame: 3 months

Secondary Outcomes

Severity of disease

Time frame: 3 months

Adverse Events

Time frame: 3 months

Data from ClinicalTrials.gov

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