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

PHASE3CompletedINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

September 14, 2017

Primary Completion Date

January 2, 2019

Study Completion Date

January 2, 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 (48)

1282

State Psychiatry Hospital Sv. Ivan Rilski, Novi Iskar

1431

University Multiprofile Hospital for Active Treatment Alexandrovska EAD, Sofia

3000

Mental Health Center - Vratsa EOOD, Vratsa

4002

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv

5000

Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo

6600

State Psychiatry Hospital - Kardzhali, Kardzhali

7003

Mental Health Center - Ruse EOOD, Rousse

7700

Multiprofile Hospital for Active Treatment - Targovishte AD, Targovishte

8000

Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Burgas

11000

Clinic for Psychiatric Disorders Dr Laza Lazarevic, Belgrade

Clinical Center of Serbia, Belgrade

Clinical Hospital Center Dr Dragisa Misovic-Dedinje, Belgrade

20877

CBH Health, Gaithersburg

21000

Clinical Center of Vojvodina, Novi Sad

26220

Special Hospital for Psychiatric Diseases Kovin, Kovin

27609

Richard H Weisler, MD, PA, and Associates, Raleigh

29407

Carolina Clinical Trials, Inc., Charleston

30325

Radiant Research Inc., Atlanta

33016

Galiz Research, Hialeah

33030

Advanced Research Institute of Miami, Homestead

33125

Optimus U Corporation, Miami

33161

Behavioral Clinical Research, Inc., North Miami

Segal Trials, North Miami

33770

Florida Behavioral Medicine, Largo

34000

Clinical Center Kragujevac, Kragujevac

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

63123

Advanced Clinical Research Center, LLC, St Louis

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

75042

Pillar Clinical Research, LLC, Garland

75080

Pillar Clinical Research, LLC, Richardson

78712

University of Texas at Austin, Austin

78754

Community Clinical Research, Inc., Austin

90230

ProScience Research Group, Culver City

91206

Behavioral Research Specialists, LLC, Glendale

91402

Asclepes Research Centers, Panorama City

92123

Sharp Vista Hospital, San Diego

92506

Ci Trials, Riverside

92845

Collaborative Neuroscience Network, LLC, Garden Grove

92868

NRC Research Institute, Orange

94607

Pacific Research Partners, LLC, Oakland

99352

Mid Columbia Research, Richland

16-070

Samodzielny Publiczny Psychiatryczny Zaklad Opieki Zdrowotnej im. Dr. Stanislawa Deresza w Choroszczy, Choroszcz

80-952

Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Psychiatrii Doroslych, Gdansk

61-485

NZOZ Centrum Medyczne HCP Sp. z o. o., Poznan

95-080

NZOZ Prywatna Klinika Psychiatryczna Inventiva, Tuszyn

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT03259555 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder | Biotech Hunter | Biotech Hunter