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

Completed

• Conditions: Mania; Manic-Depressive Psychosis; Affective Psychosis, Bipolar
• Interventions: Drug: ziprasidone

• Registration Number: NCT00454883
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 Timeline

• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-30
• Study Start: 2007-04
• Study First Posted: 2007-04-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 cohort of patients treated with ziprasidone	ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Changes in manic symptoms over course of treatment	3 months
Recording of extrapyramidal symptoms	3 months
Clinical global impression	3 months

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 months
Severity of disease	3 months