A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

PHASE4CompletedINTERVENTIONAL
Enrollment

1,270

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

June 30, 2009

Study Completion Date

October 31, 2009

Conditions
Bipolar Disorder
Interventions
DRUG

Lithium or Valproate with placebo (PBO)

"Tablets, Oral, once daily~lithium 250-2100 mg/day~valproate 250-2500mg/day~Placebo once daily"

DRUG

Lithium or Valproate with Aripiprazole

"Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)~lithium 250-2100 mg/day~valproate 250-2500mg/day~aripiprazole 15-30 mg/day"

Trial Locations (83)

4001

Local Institution, Berea

Local Institution, Durban

7002

Local Institution, Rousse

7646

Local Institution, Paarl

7708

Local Institution, Cape Town

8000

Local Institution, Burgas

10128

Neuropsychiatric Research Associates, New York

10305

Behavioral Medical Research Of Staten Island, Staten Island

10312

Richmond Behavioral Associates, Staten Island

13009

Local Institution, Marseille

21000

Local Institution, Split

21020

Local Institution, Rio de Janeiro

23000

Local Institution, Zadar

27609

Psychiatry And Clinical Research, Raleigh

30080

Carman Research, Smyrna

30900

Local Institution, Nîmes

32806

Clinical Neuroscience Solutions, Inc., Orlando

33613

University Of South Florida, Tampa

35000

Local Institution, Rennes

35404

Tuscaloosa Va Medical Center, Tuscaloosa

39100

Local Institution, Dole

40325

Local Institution, Salvador

44000

Local Institution, Nantes

44035

Local Institution, Nantes

44109

Metro Health Medical Center, Cleveland

44122

Rakesh Ranjan, Md & Associates, Inc., Beachwood

45267

University Of Cincinnati Medical Center, Cincinnati

45408

Midwest Clinical Research Center, Dayton

62251

Local Institution, Hénin-Beaumont

63128

Psych Care Consultants Research, St Louis

74922

Local Institution, Aparecida de Goinia

75002

Local Institution, Přerov

75115

Insite Clinical Research, DeSoto

75231

Futuresearch Trials, Dallas

77090

Red Oak Psychiatry Associates, Pa, Houston

78757

Senior Adults Specialty Research, Inc., Austin

83500

Local Institution, La Seyne-sur-Mer

84132

University Of Utah School Of Medicine, Salt Lake City

90703

Psychopharmacology Research Network Of Torrance, Cerritos

90822

Va Long Beach Healthcare System, Long Beach

91950

Synergy Clinical Research Center, National City

92626

Atp Clinical Research, Inc., Costa Mesa

92627

Us Clinical Research Centers, Llc, Costa Mesa

92801

Pravin Kansagra, M.D., Anaheim

92868

University Of California, Irvine Medical Center, Orange

97201

Portland Va Medical Center, Portland

98004

Northwest Clinical Research Center, Bellevue

107258

Local Institution, Moscow

175003

Local Institution, Jonzac

190000

Local Institution, Saint Petersburg

191119

Local Institution, Saint Petersburg

410028

Local Institution, Saratov

426053

Local Institution, Izhevsk

440010

Local Institution, Nāgūr

603107

Local Institution, Nizhny Novgorod

634014

Local Institution, Tomsk

6577647

Local Institution, Ahmedabad

01605

University Of Massachusetts Medical School, Worcester

08021

Cns Research Institute, P.C., Clementon

96030 003

Local Institution, Pelotas

02340

Local Institution, São Paulo

05403

Local Institution, São Paulo

51-000

Local Institution, Rijeka

10 090

Local Institution, Zagreb

610 00

Local Institution, Brno

625 00

Local Institution, Brno

736 01

Local Institution, Havířov

412 01

Local Institution, Litoměřice

120 00

Local Institution, Prague

160 00

Local Institution, Prague

500 034

Local Institution, Hyderabad

380 006

Local Institution, Ahmedabad

421 301

Local Institution, Kalyan (West)

400 001

Local Institution, Pune

576 104

Local Institution, Mangalore

400 022

Local Institution, Mumbai

110 092

Local Institution, Delhi

500 038

Local Institution, Hyderabad

400 008

Local Institution, Mumbai

400 058

Local Institution, Mumbai

110 002

Local Institution, New Delhi

110 065

Local Institution, New Delhi

0001

Local Institution, Pretoria

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT00261443 - A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania | Biotech Hunter | Biotech Hunter