Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

March 2, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Pfizer Investigational Site
    • California
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, United States, 33301
        • Pfizer Investigational Site
      • North Miami, Florida, United States, 33161
        • Pfizer Investigational Site
      • Orange City, Florida, United States, 32763
        • Pfizer Investigational Site
      • Tavares, Florida, United States, 32778
        • Pfizer Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Pfizer Investigational Site
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Pfizer Investigational Site
      • Schaumburg, Illinois, United States, 60194
        • Pfizer Investigational Site
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
      • Owensboro, Kentucky, United States, 42301
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • Pfizer Investigational Site
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Pfizer Investigational Site
      • Towson, Maryland, United States, 21204
        • Pfizer Investigational Site
      • Towson, Maryland, United States, 21286
        • Pfizer Investigational Site
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Pfizer Investigational Site
    • Mississippi
      • Meridian, Mississippi, United States, 39301
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63044-2588
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14215
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • 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, 44106-5080
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73101
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73116
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73107
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74114
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29405
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Pfizer Investigational Site
      • DeSoto, Texas, United States, 75115
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76102
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75093
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Washington
      • Kirkland, Washington, United States, 98033
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site
      • West Allis, Wisconsin, United States, 53227
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Exclusion Criteria:

  • Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo oral capsules
Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
Experimental: Ziprasidone oral capsules
Drug: Ziprasidone oral capsules
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
Time Frame: Baseline, Week 4
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
Baseline, Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3
Time Frame: Baseline, Week 1, 2, 3
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
Baseline, Week 1, 2, 3
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4
Time Frame: Baseline, Week 1, 2, 3, 4
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).
Baseline, Week 1, 2, 3, 4
Clinical Global Impression - Improvement (CGI-I) Score
Time Frame: Week 1, 2, 3, 4
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Week 1, 2, 3, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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