A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

333

Participants

Timeline

Start Date

September 19, 2017

Primary Completion Date

January 22, 2019

Study Completion Date

January 22, 2019

Conditions
Bipolar I DisorderManic Episode
Interventions
DRUG

Brexpiprazole

Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.

DRUG

Placebo

Administered orally daily for 3 weeks.

Trial Locations (38)

11432

CNS Research Science, Inc., Jamaica

21005

"Communal Establishment Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital", Vinnytsia

28211

New Hope Clinical Research, Charlotte

30030

iResearch Atlanta, LLC, Decatur

32801

Meridien Research, Orlando

33016

Galiz Research, Hialeah

33024

Research Centers of America LLC, Hollywood

33125

Optimus U Corporation, Miami

33166

South Florida Research Phase I-IV, Miami Springs

36013

O.F. Maltsev Poltava Regional Psychiatric Hospital, Poltava

45219

University of Cincinnati Department of Psychiatry and Behavorial Science, Cincinnati

46027

Ternopil Regional Municipal Clinical Psychoneurolgical Hospital, Ternopil

49005

"Communal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov", Dnipro

51000

Clinical Hospital Centre Rijeka, Rijeka

60190

Neuropsychiatric Research & Associates, LTD, Winfield

60640

Uptown Research Institute LLC, Chicago

61068

"SI Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine", Kharkiv

63118

Arch Clinical Trials, LLC, St Louis

63141

St Louis Clinical Trials LLC, St Louis

67513

"Communal Establishment Odesa Regional Psychiatric Hospital #2", Oleksandrivka

71101

Louisiana Clinical Research, Shreveport

72209

Atria Clinical Research, Little Rock

72211

Woodland International Research Group, LLC, Little Rock

73488

"Communal Establishment Kherson Regional Psychiatric Hospital of Kherson Regional Council", Kherson

75080

Pillar Clinical Research, LLC, Richardson

75115

InSite Clinical Research LLC, DeSoto

79021

"Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #20", Lviv

"Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25", Lviv

90502

Collaborative Neuroscience Network, LLC, Torrance

90703

CNS Research Science Inc., Cerritos

90706

CiTrials, Bellflower

90813

Apostle Clinical Trials, Long Beach

92102

CNRI-San Diego, San Diego

92103

Artemis Institute for Clinical Research, San Diego

92705

CiTrials, Santa Ana

92886

Shreenath Clinical Service, Yorba Linda

08009

Hassman Research Institute, Berlin

04080

"Kyiv Regional Medical Incorporation Psychiatry, Center for Novel Treatment and Rehabilitation of Psychotic disorders", Kyiv

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT03257865 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder | Biotech Hunter | Biotech Hunter