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

Bipolar Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257166
• Other study ID #: A1281132
• Status: Completed
• Phase: Phase 3
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Ziprasidone oral capsules
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
• placebo oral capsules
Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altamonte Springs	Florida
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Clinton Township	Michigan
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Des Plaines	Illinois
United States	Pfizer Investigational Site	DeSoto	Texas
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Meridian	Mississippi
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Orange City	Florida
United States	Pfizer Investigational Site	Owensboro	Kentucky
United States	Pfizer Investigational Site	Pikesville	Maryland
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Schaumburg	Illinois
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Tavares	Florida
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Towson	Maryland
United States	Pfizer Investigational Site	Towson	Maryland
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	West Allis	Wisconsin

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 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
Secondary	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 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
Secondary	Clinical Global Impression - Improvement (CGI-I) Score	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

External Links

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