Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
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)
1 other identifier
interventional
238
1 country
50
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2006
50 active sites
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
First Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedResults Posted
Study results publicly available
July 19, 2013
CompletedMarch 3, 2021
March 1, 2021
1.5 years
November 21, 2005
May 24, 2013
March 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Young Mania Rating Scale (YMRS) Score at 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 Outcomes (3)
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3
Baseline, Week 1, 2, 3
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4
Baseline, Week 1, 2, 3, 4
Clinical Global Impression - Improvement (CGI-I) Score
Week 1, 2, 3, 4
Study Arms (2)
Ziprasidone oral capsules
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
Eligibility Criteria
You may qualify if:
- DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Pfizer Investigational Site
Scottsdale, Arizona, 85251, United States
Pfizer Investigational Site
Orange, California, 92868, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Altamonte Springs, Florida, 32701, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33301, United States
Pfizer Investigational Site
North Miami, Florida, 33161, United States
Pfizer Investigational Site
Orange City, Florida, 32763, United States
Pfizer Investigational Site
Tavares, Florida, 32778, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Honolulu, Hawaii, 96826, United States
Pfizer Investigational Site
Des Plaines, Illinois, 60016, United States
Pfizer Investigational Site
Schaumburg, Illinois, 60194, United States
Pfizer Investigational Site
Terre Haute, Indiana, 47802, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
Owensboro, Kentucky, 42301, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71103, United States
Pfizer Investigational Site
Pikesville, Maryland, 21208, United States
Pfizer Investigational Site
Towson, Maryland, 21204, United States
Pfizer Investigational Site
Towson, Maryland, 21286, United States
Pfizer Investigational Site
Clinton Township, Michigan, 48038, United States
Pfizer Investigational Site
Meridian, Mississippi, 39301, United States
Pfizer Investigational Site
St Louis, Missouri, 63044-2588, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68510, United States
Pfizer Investigational Site
Omaha, Nebraska, 68131, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87102, United States
Pfizer Investigational Site
Buffalo, New York, 14215, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45224, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45229, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106-5080, United States
Pfizer Investigational Site
Columbus, Ohio, 43210, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73101, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73107, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73116, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74114, United States
Pfizer Investigational Site
Charleston, South Carolina, 29405, United States
Pfizer Investigational Site
Arlington, Texas, 76011, United States
Pfizer Investigational Site
DeSoto, Texas, 75115, United States
Pfizer Investigational Site
Fort Worth, Texas, 76102, United States
Pfizer Investigational Site
Lake Jackson, Texas, 77566, United States
Pfizer Investigational Site
Plano, Texas, 75093, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Kirkland, Washington, 98033, United States
Pfizer Investigational Site
Spokane, Washington, 99204, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226, United States
Pfizer Investigational Site
West Allis, Wisconsin, 53227, United States
Related Publications (1)
Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.
PMID: 24111980DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 22, 2005
Study Start
January 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
March 3, 2021
Results First Posted
July 19, 2013
Record last verified: 2021-03