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

NCT00265330 | Completed Phase 3 Results DMC

• 1 other identifier: A1281133
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 41

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)

Conditions

Bipolar Disorder

Keywords

Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Outcome Measures

Primary Outcomes (19)

• Young Mania Rating Scale (YMRS) Total Score Change From Baseline

  YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.

  baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)

• Clinical Global Impression of Severity (CGI-S) Change From Baseline

  CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).

  baseline and 26 Weeks; 26 Weeks LOCF

• Incidence of Lab Abnormalities

  number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.

  Week 26

• Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol

  Mean Change: lab value at observation minus lab value at baseline.

  Week 6, Week 26

• Change in Hormones

  Mean Change: lab value at observation minus lab value at baseline

  Week 6, Week 26

• Mean Change From Baseline in Supine Systolic Blood Pressure

  Mean Change: vital sign value at observation minus vital sign value at baseline

  Week 1 through Week 26

• Mean Change From Baseline in Supine Diastolic Blood Pressure

  Mean Change: vital sign value at observation minus vital sign value at baseline

  Week 1 through Week 26

• Mean Change From Baseline in Supine Pulse Rates

  Mean Change: vital sign value at observation minus vital sign value at baseline

  Week 1 through Week 26

• Mean Change From Baseline in Standing Systolic Blood Pressure

  Mean Change: vital sign value at observation minus vital sign value at baseline

  Week 1 through Week 26

• Mean Change From Baseline in Standing Diastolic Blood Pressure

  Mean Change: vital sign value at observation minus vital sign value at baseline

  Week 1 through Week 26

• Mean Change From Baseline in Standing Pulse Rates

  Mean Change: vital sign value at observation minus vital sign value at baseline

  Week 1 through Week 26

• Mean Change From Baseline for Body Weight

  Mean change; body weight value at observation minus body weight value at baseline.

  Week 6, Week 26

• Mean Change From Baseline for Body Mass Index (BMI) Z-Score

  mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change

  Week 6, 26, early termination

• Body Mass Index (BMI) Z-score Frequency

  change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change

  Week 6

• Body Mass Index (BMI) Z-score Frequency

  change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change

  Week 26

• Mean Change From Baseline for QTcF Intervals

  QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.

  Baseline to Week 26 (end of study)

• Frequency of Largest Categorical Increases in QTcF for Males

  QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  Week 26 (end of study)

• Frequency of Largest Categorical Increases in QTcF for Females

  QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  Week 26 (end of study)

• Frequency of Largest Categorical Increases in QTcF - All Subjects

  QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  Week 26 (end of study)

Study Arms (1)

Open

EXPERIMENTAL

Drug: Ziprasidone oral capsules

Interventions

Ziprasidone oral capsules DRUG

Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Open

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (41)

Pfizer Investigational Site

Scottsdale, Arizona, 85251, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

Location

Pfizer Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

Pfizer Investigational Site

Fort Lauderdale, Florida, 33301, United States

Location

Pfizer Investigational Site

North Miami, Florida, 33161, United States

Location

Pfizer Investigational Site

Orange City, Florida, 32763, United States

Location

Pfizer Investigational Site

Tavares, Florida, 32778, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30033, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96826, United States

Location

Pfizer Investigational Site

Terre Haute, Indiana, 47802, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Pfizer Investigational Site

Owensboro, Kentucky, 42301, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71103, United States

Location

Pfizer Investigational Site

Clinton Township, Michigan, 48038, United States

Location

Pfizer Investigational Site

Meridian, Mississippi, 39301, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63044-2588, United States

Location

Pfizer Investigational Site

Lincoln, Nebraska, 68510, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Pfizer Investigational Site

Rochester, New York, 14618, 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, 44106-5080, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43210, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73101, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73107, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73116, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, 74114, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29405, United States

Location

Pfizer Investigational Site

Arlington, Texas, 76011, United States

Location

Pfizer Investigational Site

DeSoto, Texas, 75115, United States

Location

Pfizer Investigational Site

Lake Jackson, Texas, 77566, United States

Location

Pfizer Investigational Site

Plano, Texas, 75093, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Kirkland, Washington, 98033, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99204, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Pfizer Investigational Site

West Allis, Wisconsin, 53227, United States

Location

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: 24111980 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 25, 2021
• Results First Posted: April 3, 2009

Record last verified: 2021-03

Locations

US (41)