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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Intervention / Treatment: Drug: Ziprasidone; Drug: Ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92111
      • Pfizer Investigational Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Pfizer Investigational Site
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Pfizer Investigational Site
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Pfizer Investigational Site
    • Brighton, Massachusetts, United States, 02135
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89103
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89128
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89117
      • Pfizer Investigational Site
  • New Jersey
    • Turnersville, New Jersey, United States, 08012
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45229
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45224
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44106
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-3309
      • Pfizer Investigational Site
  • Washington
    • Kirkland, Washington, United States, 98033
      • Pfizer Investigational Site
    • Kirkland, Washington, United States, 98034
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-Dose Ziprasidone	Drug: Ziprasidone; 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; Drug: Ziprasidone; Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 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
Active Comparator: High-Dose Ziprasidone	Drug: Ziprasidone; 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; Drug: Ziprasidone; Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.	27 weeks
Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.	27 weeks
Laboratory data at Screening and Weeks 3, 12, and 27.	27 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.	3 weeks
Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.	27 weeks
Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.	27 weeks
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.	27 weeks
Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.	27 weeks
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.	27 weeks
Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.	27 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 2, 2008

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: A1281123