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OpenTrials
Completed

NCT Number: NCT00454883

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

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

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Key information

Conditions

Affective Psychosis, Bipolar Bipolar Disorder Bipolar and Related Disorders Mania Manic-Depressive Psychosis Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziprasidone

Drug

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.

Other names: Geodon, Zeldox

Primary outcomes

  1. Clinical global impression

    Time frame: 3 months

  2. Recording of extrapyramidal symptoms

    Time frame: 3 months

  3. Changes in manic symptoms over course of treatment

    Time frame: 3 months

Secondary outcomes

  1. Severity of disease

    Time frame: 3 months

  2. Adverse Events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 2, 2007
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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