Clinical trial NCT00265330: Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Official title: 26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 169
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)


Eligibility criteria: Inclusion Criteria:

* Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.

Primary outcomes:
measure: Young Mania Rating Scale (YMRS) Total Score Change From Baseline
timeFrame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)
measure: Clinical Global Impression of Severity (CGI-S) Change From Baseline
timeFrame: baseline and 26 Weeks; 26 Weeks LOCF
measure: Incidence of Lab Abnormalities
timeFrame: Week 26
measure: Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
timeFrame: Week 6, Week 26
measure: Change in Hormones
timeFrame: Week 6, Week 26
measure: Mean Change From Baseline in Supine Systolic Blood Pressure
timeFrame: Week 1 through Week 26
measure: Mean Change From Baseline in Supine Diastolic Blood Pressure
timeFrame: Week 1 through Week 26
measure: Mean Change From Baseline in Supine Pulse Rates
timeFrame: Week 1 through Week 26
measure: Mean Change From Baseline in Standing Systolic Blood Pressure
timeFrame: Week 1 through Week 26
measure: Mean Change From Baseline in Standing Diastolic Blood Pressure
timeFrame: Week 1 through Week 26
measure: Mean Change From Baseline in Standing Pulse Rates
timeFrame: Week 1 through Week 26
measure: Mean Change From Baseline for Body Weight
timeFrame: Week 6, Week 26
measure: Mean Change From Baseline for Body Mass Index (BMI) Z-Score
timeFrame: Week 6, 26, early termination
measure: Body Mass Index (BMI) Z-score Frequency
timeFrame: Week 6
measure: Body Mass Index (BMI) Z-score Frequency
timeFrame: Week 26
measure: Mean Change From Baseline for QTcF Intervals
timeFrame: Baseline to Week 26 (end of study)
measure: Frequency of Largest Categorical Increases in QTcF for Males
timeFrame: Week 26 (end of study)
measure: Frequency of Largest Categorical Increases in QTcF for Females
timeFrame: Week 26 (end of study)
measure: Frequency of Largest Categorical Increases in QTcF - All Subjects
timeFrame: Week 26 (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Altamonte Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tavares
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Owensboro
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Clinton Township
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Meridian
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: West Allis
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.