NCT00650611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

First QC Date

March 28, 2008

Last Update Submit

February 18, 2021

Conditions

SchizophreniaBipolar DisorderSchizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Low-Dose Ziprasidone

ACTIVE COMPARATOR
Drug: Ziprasidone

High-Dose Ziprasidone

ACTIVE COMPARATOR
Drug: Ziprasidone

Interventions

ZiprasidoneDRUG

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.

Also known as: Geodon, Zeldox
High-Dose Ziprasidone

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pfizer Investigational Site

San Diego, California, 92111, United States

Location

Pfizer Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

Pfizer Investigational Site

Libertyville, Illinois, 60048, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Pfizer Investigational Site

Belmont, Massachusetts, 02478, United States

Location

Pfizer Investigational Site

Brighton, Massachusetts, 02135, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89103, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89117, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Pfizer Investigational Site

Turnersville, New Jersey, 08012, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45224, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45267-0559, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Pfizer Investigational Site

Kirkland, Washington, 98033, United States

Location

Pfizer Investigational Site

Kirkland, Washington, 98034, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPsychotic Disorders

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 2, 2008

Study Start

December 1, 2003

Study Completion

March 1, 2005

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(17)