Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

PHASE3CompletedINTERVENTIONAL
Enrollment

584

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Bipolar ManiaBipolar Disorder
Interventions
DRUG

Placebo

Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.

DRUG

Ziprasidone Oral Capsule

Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.

Trial Locations (107)

110

Pfizer Investigational Site, Taipei

112

Pfizer Investigational Site, Taipei

1010

Pfizer Investigational Site, Caracas

1050

Pfizer Investigational Site, Caracas

13509

Pfizer Investigational Site, Berlin

14050

Pfizer Investigational Site, Berlin

14215

Pfizer Investigational Site, Buffalo

14618

Pfizer Investigational Site, Rochester

14760

Pfizer Investigational Site, Olean

15206

Pfizer Investigational Site, Pittsburgh

15213

Pfizer Investigational Site, Pittsburgh

16000

Pfizer Investigational Site, Angoulême

19063

Pfizer Investigational Site, Media

20852

Pfizer Investigational Site, Rockville

21285

Pfizer Investigational Site, Baltimore

27609

Pfizer Investigational Site, Raleigh

28007

Pfizer Investigational Site, Madrid

29240

Pfizer Investigational Site, Brest Naval

30033

Pfizer Investigational Site, Decatur

30080

Pfizer Investigational Site, Smyrna

32216

Pfizer Investigational Site, Jacksonville

32701

Pfizer Investigational Site, Altamonte Springs

32751

Pfizer Investigational Site, Maitland

32778

Pfizer Investigational Site, Tavares

32806

Pfizer Investigational Site, Orlando

33016

Pfizer Investigational Site, Miami

33126

Pfizer Investigational Site, Miami

33161

Pfizer Investigational Site, North Miami

33319

Pfizer Investigational Site, Fort Lauderdale

33912

Pfizer Investigational Site, Fort Myers

35226

Pfizer Investigational Site, Birmingham

35294

Pfizer Investigational Site, Birmingham

35924

Pfizer Investigational Site, Birmingham

38117

Pfizer Investigational Site, Memphis

38654

Pfizer Investigational Site, Olive Branch

39157

Pfizer Investigational Site, Ridgeland

40509

Pfizer Investigational Site, Lexington

42301

Pfizer Investigational Site, Owensboro

43100

Pfizer Investigational Site, Parma

43210

Pfizer Investigational Site, Columbus

43609

Pfizer Investigational Site, Toledo

45136

Pfizer Investigational Site, Essen

45200

Pfizer Investigational Site, Zapopan

47802

Pfizer Investigational Site, Terre Haute

50134

Pfizer Investigational Site, Florence

56126

Pfizer Investigational Site, Pisa

59500

Pfizer Investigational Site, Douai

60016

Pfizer Investigational Site, Des Plaines

60048

Pfizer Investigational Site, Libertyville

60194

Pfizer Investigational Site, Schaumburg

60523

Pfizer Investigational Site, Oak Brook

60540

Pfizer Investigational Site, Naperville

60563

Pfizer Investigational Site, Naperville

63301

Pfizer Investigational Site, Saint Charles

66606

Pfizer Investigational Site, Topeka

67207

Pfizer Investigational Site, Wichita

68100

Pfizer Investigational Site, Mulhouse

68131

Pfizer Investigational Site, Omaha

68506

Pfizer Investigational Site, Lincoln

68510

Pfizer Investigational Site, Lincoln

72223

Pfizer Investigational Site, Little Rock

73008

Pfizer Investigational Site, Bethany

73103

Pfizer Investigational Site, Oklahoma City

73116

Pfizer Investigational Site, Oklahoma City

75115

Pfizer Investigational Site, DeSoto

75231

Pfizer Investigational Site, Dallas

76012

Pfizer Investigational Site, Arlington

77008

Pfizer Investigational Site, Houston

77054

Pfizer Investigational Site, Houston

77057

Pfizer Investigational Site, Houston

77401

Pfizer Investigational Site, Bellaire

78756

Pfizer Investigational Site, Austin

85251

Pfizer Investigational Site, Scottsdale

89106

Pfizer Investigational Site, Las Vegas

90026

Pfizer Investigational Site, Los Angeles

91950

Pfizer Investigational Site, National City

92108

Pfizer Investigational Site, San Diego

92590

Pfizer Investigational Site, Temecula

92591

Pfizer Investigational Site, Temecula

92626

Pfizer Investigational Site, Costa Mesa

93413

Pfizer Investigational Site, Cham

95123

Pfizer Investigational Site, Catania

95823

Pfizer Investigational Site, Sacramento

96826

Pfizer Investigational Site, Honolulu

141001

Pfizer Investigational Site, Ludhiana

141371

Pfizer Investigational Site, Khot'kovo

163530

Pfizer Investigational Site, Arkhangelskaya Obl, Primorsky Raion

570004

Pfizer Investigational Site, Mysore

01201

Pfizer Investigational Site, Pittsfield

02780

Pfizer Investigational Site, Taunton

03060

Pfizer Investigational Site, Nashua

07652

Pfizer Investigational Site, Paramus

07666

Pfizer Investigational Site, Teaneck

45267-0559

Pfizer Investigational Site, Cincinnati

75390-9121

Pfizer Investigational Site, Dallas

Unknown

Pfizer Investigational Site, Santiago

Pfizer Investigational Site, Santiago

Pfizer Investigational Site, Guatemala City

Pfizer Investigational Site, New Territories

380 006

Pfizer Investigational Site, Ellisbridge

517 507

Pfizer Investigational Site, Tirupati

560 010

Pfizer Investigational Site, Bangalore

600 003

Pfizer Investigational Site, Chennai

411 030

Pfizer Investigational Site, Pune

03740

Pfizer Investigational Site, Mexico City

08019

Pfizer Investigational Site, Barcelona

08036

Pfizer Investigational Site, Barcelona

All Listed Sponsors
lead

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

INDUSTRY

NCT00280566 - Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed) | Biotech Hunter | Biotech Hunter