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

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Bipolar Disorder
Interventions
DRUG

Ziprasidone oral capsules

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 .

Trial Locations (41)

14618

Pfizer Investigational Site, Rochester

29405

Pfizer Investigational Site, Charleston

30033

Pfizer Investigational Site, Decatur

32701

Pfizer Investigational Site, Altamonte Springs

32763

Pfizer Investigational Site, Orange City

32778

Pfizer Investigational Site, Tavares

33161

Pfizer Investigational Site, North Miami

33301

Pfizer Investigational Site, Fort Lauderdale

39301

Pfizer Investigational Site, Meridian

40509

Pfizer Investigational Site, Lexington

42301

Pfizer Investigational Site, Owensboro

43210

Pfizer Investigational Site, Columbus

45224

Pfizer Investigational Site, Cincinnati

45229

Pfizer Investigational Site, Cincinnati

47802

Pfizer Investigational Site, Terre Haute

48038

Pfizer Investigational Site, Clinton Township

53226

Pfizer Investigational Site, Milwaukee

53227

Pfizer Investigational Site, West Allis

68131

Pfizer Investigational Site, Omaha

68510

Pfizer Investigational Site, Lincoln

71103

Pfizer Investigational Site, Shreveport

73101

Pfizer Investigational Site, Oklahoma City

73107

Pfizer Investigational Site, Oklahoma City

73112

Pfizer Investigational Site, Oklahoma City

73116

Pfizer Investigational Site, Oklahoma City

74114

Pfizer Investigational Site, Tulsa

75093

Pfizer Investigational Site, Plano

75115

Pfizer Investigational Site, DeSoto

76011

Pfizer Investigational Site, Arlington

77566

Pfizer Investigational Site, Lake Jackson

78229

Pfizer Investigational Site, San Antonio

80045

Pfizer Investigational Site, Aurora

85251

Pfizer Investigational Site, Scottsdale

87102

Pfizer Investigational Site, Albuquerque

92123

Pfizer Investigational Site, San Diego

96826

Pfizer Investigational Site, Honolulu

98033

Pfizer Investigational Site, Kirkland

99204

Pfizer Investigational Site, Spokane

63044-2588

Pfizer Investigational Site, St Louis

45267-0559

Pfizer Investigational Site, Cincinnati

44106-5080

Pfizer Investigational Site, Cleveland

All Listed Sponsors
lead

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

INDUSTRY

NCT00265330 - Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed) | Biotech Hunter | Biotech Hunter