Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

PHASE3CompletedINTERVENTIONAL
Enrollment

298

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Bipolar DisorderDepression, Bipolar
Interventions
DRUG

Ziprasidone

Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.

DRUG

Placebo

Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm

Trial Locations (70)

2145

Pfizer Investigational Site, Westmead

3121

Pfizer Investigational Site, Richmond

4000

Pfizer Investigational Site, Spring Hill

4053

Pfizer Investigational Site, Everton Park

10023

Pfizer Investigational Site, New York

10312

Pfizer Investigational Site, Staten Island

11004

Pfizer Investigational Site, Glen Oaks

11201

Pfizer Investigational Site, Brooklyn

14618

Pfizer Investigational Site, Rochester

14760

Pfizer Investigational Site, Olean

19104

Pfizer Investigational Site, Philadelphia

19139

Pfizer Investigational Site, Philadelphia

20852

Pfizer Investigational Site, Rockville

22903

Pfizer Investigational Site, Charlottesville

27599

Pfizer Investigational Site, Chapel Hill

32771

Pfizer Investigational Site, Sanford

32806

Pfizer Investigational Site, Orlando

33407

Pfizer Investigational Site, West Palm Beach

33486

Pfizer Investigational Site, Boca Raton

33702

Pfizer Investigational Site, St. Petersburg

38117

Pfizer Investigational Site, Memphis

43210

Pfizer Investigational Site, Columbus

45227

Pfizer Investigational Site, Cincinnati

45408

Pfizer Investigational Site, Dayton

46143

Pfizer Investigational Site, Greenwood

46260

Pfizer Investigational Site, Indianapolis

48038

Pfizer Investigational Site, Clinton Township

53223

Pfizer Investigational Site, Brown Deer

60077

Pfizer Investigational Site, Skokie

60640

Pfizer Investigational Site, Chicago

63301

Pfizer Investigational Site, Saint Charles

66606

Pfizer Investigational Site, Topeka

67207

Pfizer Investigational Site, Wichita

68510

Pfizer Investigational Site, Lincoln

70601

Pfizer Investigational Site, Lake Charles

72211

Pfizer Investigational Site, Little Rock

72223

Pfizer Investigational Site, Little Rock

72762

Pfizer Investigational Site, Springdale

73116

Pfizer Investigational Site, Oklahoma City

73119

Pfizer Investigational Site, Oklahoma City

77040

Pfizer Investigational Site, Houston

77074

Pfizer Investigational Site, Houston

77566

Pfizer Investigational Site, Lake Jackson

78754

Pfizer Investigational Site, Austin

78756

Pfizer Investigational Site, Austin

85226

Pfizer Investigational Site, Chandler

85340

Pfizer Investigational Site, Litchfield Park

90502

Pfizer Investigational Site, Torrance

92056

Pfizer Investigational Site, Oceanside

92108

Pfizer Investigational Site, San Diego

92627

Pfizer Investigational Site, Costa Mesa

97210

Pfizer Investigational Site, Portland

98033

Pfizer Investigational Site, Kirkland

98104

Pfizer Investigational Site, Seattle

99352

Pfizer Investigational Site, Richland

110027

Pfizer Investigational Site, Delhi

431005

Pfizer Investigational Site, Aurangabad

33486-1340

Pfizer Investigational Site, Boca Raton

32256-2006

Pfizer Investigational Site, Jacksonville

02135

Pfizer Investigational Site, Boston

02472

Pfizer Investigational Site, Watertown

63044-2588

Pfizer Investigational Site, St Louis

03060

Pfizer Investigational Site, Nashua

08002

Pfizer Investigational Site, Cherry Hill

08021

Pfizer Investigational Site, Clementon

45267-0516

Pfizer Investigational Site, Cincinnati

380 006

Pfizer Investigational Site, Ellisbridge

Pfizer Investigational Site, Ahmedabad

411 001

Pfizer Investigational Site, Pune

411 004

Pfizer Investigational Site, Pune

All Listed Sponsors
lead

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

INDUSTRY

NCT00483548 - Adjunctive Ziprasidone in the Treatment of Bipolar I Depression | Biotech Hunter | Biotech Hunter