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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00650611
Collaborator
(none)
63
17
2
15
3.7
0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Dec 1, 2003
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Low-Dose Ziprasidone

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
  • Outcome Measures

    Primary Outcome Measures

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

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

    3. Laboratory data at Screening and Weeks 3, 12, and 27. [27 weeks]

    Secondary Outcome Measures

    1. Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3. [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. [27 weeks]

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site San Diego California United States 92111
    2 Pfizer Investigational Site Altamonte Springs Florida United States 32701
    3 Pfizer Investigational Site Libertyville Illinois United States 60048
    4 Pfizer Investigational Site Lexington Kentucky United States 40509
    5 Pfizer Investigational Site Belmont Massachusetts United States 02478
    6 Pfizer Investigational Site Brighton Massachusetts United States 02135
    7 Pfizer Investigational Site Las Vegas Nevada United States 89103
    8 Pfizer Investigational Site Las Vegas Nevada United States 89117
    9 Pfizer Investigational Site Las Vegas Nevada United States 89128
    10 Pfizer Investigational Site Turnersville New Jersey United States 08012
    11 Pfizer Investigational Site Cincinnati Ohio United States 45224
    12 Pfizer Investigational Site Cincinnati Ohio United States 45229
    13 Pfizer Investigational Site Cincinnati Ohio United States 45267-0559
    14 Pfizer Investigational Site Cleveland Ohio United States 44106
    15 Pfizer Investigational Site Philadelphia Pennsylvania United States 19104-3309
    16 Pfizer Investigational Site Kirkland Washington United States 98033
    17 Pfizer Investigational Site Kirkland Washington United States 98034

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00650611
    Other Study ID Numbers:
    • A1281123
    First Posted:
    Apr 2, 2008
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021

    Study Results

    No Results Posted as of Feb 21, 2021