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

Mania Clinical Trial

Official title:

Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454883
• Other study ID #: A1281159
• Status: Completed
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Affective Psychosis, Bipolar
• Bipolar Disorder
• Mania
• Manic-Depressive Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical global impression		3 months
Primary	Recording of extrapyramidal symptoms		3 months
Primary	Changes in manic symptoms over course of treatment		3 months
Secondary	Severity of disease		3 months
Secondary	Adverse Events		3 months

External Links

•   To obtain contact information for a study center near you, click here.