A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Bipolar I DisorderAcute Mania
Interventions
DRUG

Brexpiprazole

Brexpiprazole tablets

Trial Locations (73)

1282

State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department, Novi Iskar

1431

University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry, Sofia

3000

Mental Health Center - Vratsa EOOD, Department of Psychiatry, Vratsa

4002

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry, Plovdiv

5000

Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders, Veliko Tarnovo

6600

State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department, Kardzhali

7003

"Mental Health Centre-Ruse EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders", Rousse

7700

Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry, Targovishte

8000

Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition, Burgas

10000

Poliklinika Neuron /Polyclinic Neuron, Zagreb

11000

CHC Dr Dragisa Misovic, Belgrade

Clinic for Psychiatric Disorders, Dr Laza Lazarevic, Belgrade

Clinic for Psychiatry, Belgrade

20877

CBH Health, Gaithersburg

21000

Klinika za psihijariju, Klinicki Centar Vojvodine, Novi Sad

21018

O.I. Yushenko Vinnitsa Regional Clinic, Vinnitsa

26220

Specialized Hospital for Psychiatry Diseases Kovin, Kovin

27609

Richard H Weisler, MD PA Associates, Raleigh

28601

Clinical Trials of America-NC, LLC, Hickory

30030

iResearch Atlanta, LLC, Decatur

33016

Galiz Research, Hialeah

33024

Research Centers of America, LLC, Hollywood

33134

Optimus U Corp, Coral Gables

33308

Segal Trials, Fort Lauderdale

33613

University of South Florida Board of Trustees, Tampa

33770

Florida Behavioral Medicine, Largo

34000

Clinical Center Kragujevac, Clinic of Psychiatry, Kragujevac

36013

Maltsev Regional Clinical Psychiatric Hospital, Poltava

46027

Ternopil Regional Municipal Clinical Psychoneurological Hospital, Ternopil

49005

Regional Clinical Hospital n.a I.I. Mechnicov, Dnipro

51000

CHC Rijeka-Clinic for Psychiatrics, Rijeka

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

60190

NeuroPsychiatric Research, Winfield

61068

SI of Neurology Psychiatry and Narcology NAMS, Kharkiv

63118

Arch Clinical Trials, LLC, St Louis

63141

St. Louis Clinical Trials, St Louis

63304

St. Charles Psychiatric Associates, Saint Charles

67513

Odesa Regional Psychiatric Hospital 2, Odesa

71101

Louisiana Clinical Research, Shreveport

72211

Woodland International Research Group, Little Rock

72758

Woodland Research Northwest, LLC, Rogers

73112

SP Research PLLC, Oklahoma City

73116

Cutting Edge Research Group, Oklahoma City

73488

Kherson Regional Psychiatric Hospital, Kherson

75042

Pillar Clinical Research LLC, Garland

75080

Pillar Clinical Research, LLC, Richardson

75115

InSite Clinical Research, DeSoto

76104

North Texas Clinical Trials, Fort Worth

78754

Community Clinical Research, Inc., Austin

79021

CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25, Lviv

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

90230

ProScience Research Group, Culver City

90502

Collaborative Neuroscience Network, LLC, Torrance

90703

Radiant Research, Cerritos

90706

Citrials Inc., Bellflower

90813

Apostle Clinical Trials, Long Beach

91206

Behavioral Research Specialists, LLC, Glendale

91402

Asclepes Research Centers, PC, Panorama City

92102

CNRI-San Diego, San Diego

92103

Artemis Institute for Clinical Research, San Diego

92123

Sharp Mesa Vista Hospital, San Diego

92705

CI Trials, Riverside

CI Trials, Santa Ana

92845

Collaborative Neuroscience Network, LLC, Garden Grove

92868

NRC Research Institute, Orange

92886

Shreenath Clinical Service, Yorba Linda

94607

Pacific Research Partners, LLC, Oakland

98201

Core Clinical Research, Everett

99352

Mid Columbia Research, Richland

08009

Hassman Research Institute, LLC, Berlin

80-438

Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala, Gdansk

95-080

NZOZ Prywatna Klinika Psychiatryczna Inventiva, Tuszyn

04080

Kyiv Regional Medical Incorporation Psychiatry, Kyiv

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT03287869 - A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. | Biotech Hunter | Biotech Hunter