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

Overview

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

Full Title of Study: “Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2007

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

  • 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.

Arms, Groups and Cohorts

  • 1 cohort of patients treated with ziprasidone

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Severity of disease
    • Time Frame: 3 months
  • Adverse Events
    • Time Frame: 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.