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Completed

NCT Number: NCT00650611

A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
  • Willingness to discontinue all antipsychotic medications during the study period

Exclusion criteria

  • Patients who are clinically stable on treatments that are well tolerated
  • Substance-induced psychotic disorders

Treatment and study plan

Ziprasidone

Drug

Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.

Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.

Other names: Geodon, Zeldox

Primary outcomes

  1. Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.

    Time frame: 27 weeks

  2. Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.

    Time frame: 27 weeks

  3. Laboratory data at Screening and Weeks 3, 12, and 27.

    Time frame: 27 weeks

Secondary outcomes

  1. Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.

    Time frame: 3 weeks

  2. Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.

    Time frame: 27 weeks

  3. Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.

    Time frame: 27 weeks

  4. Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.

    Time frame: 27 weeks

  5. Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.

    Time frame: 27 weeks

  6. Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.

    Time frame: 27 weeks

  7. Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.

    Time frame: 27 weeks

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder

Important dates

Study start
2003
Study completion
2005
First posted
Apr 2, 2008
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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