The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

752

Participants

Timeline

Start Date

November 10, 2018

Primary Completion Date

September 6, 2021

Study Completion Date

September 6, 2021

Conditions
Major Depressive Disorder
Interventions
DRUG

Cariprazine

Cariprazine supplied in capsules

DRUG

Placebo

Placebo supplied in capsules

DRUG

Antidepressant Therapy (ADT)

ADT as prescribed by the physician per standard of care in clinical practice.

Trial Locations (112)

10128

Eastside Comprehensive Medical Center LLC /ID# 236094, New York

11000

Military Medical Academy /ID# 237062, Belgrade

University Clinical Center Serbia /ID# 237747, Belgrade

Bel Medic - General Hospital /ID# 236171, Belgrade

11040

Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299, Belgrade

11108

Institute of Mental Health /ID# 236481, Belgrade

13000

Special Psychiatric Hospital /ID# 235152, Vršac

18000

University Clinical Center of Nis /ID# 236973, Niš

19462

Keystone Clinical Studies LLC /ID# 238153, Plymouth Meeting

23330

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716, Novi Kneževac

26100

Satakunnan Psykiatripalvelu Oy /ID# 234936, Rauma

26220

Special Hospital for Psychiatric Diseases Kovin /ID# 234691, Kovin

28601

Clinical Trials America /ID# 237636, Hickory

30331

Atlanta Center for Medical Research /ID# 234696, Atlanta

30341

Institute for Advanced Medical Research /ID# 234992, Atlanta

31405

iResearch Savannah /ID# 236082, Savannah

32763

Medical Research Group of Central Florida /ID# 237326, Orange City

32905

Space Coast Neuropsychiatric Research Institute /ID# 235766, Palm Bay

33133

Innova Clinical Trials /ID# 237376, Miami

33183

International Research Associates, LLC /ID# 237410, Miami

33200

Psykiatri- ja psykologikeskus Mentoria /ID# 235091, Tampere

33319

Innovative Clinical Research /ID# 235186, Fort Lauderdale

33912

Gulfcoast Clinical Research Center /ID# 236280, Fort Myers

34000

University Clinical Center Kragujevac /ID# 237750, Kragujevac

University Clinical Center Kragujevac /ID# 237752, Kragujevac

University Clinical Center Kragujevac /ID# 237753, Kragujevac

36303

Harmonex /ID# 236936, Dothan

37067

Psychiatric Consultants PC /ID# 235838, Franklin

44012

Quest Therapeutics of Avon Lake /ID# 236281, Avon Lake

44130

North Star Medical Research LL /ID# 235076, Middleburg Heights

45069

CincyScience /ID# 236387, West Chester

53715

SSM Health Dean Medical Group /ID# 238103, Madison

60563

AMR Conventions Research /ID# 236262, Naperville

66208

Collective Medical Research /ID# 236397, Prairie Village

70100

Savon Psykiatripalvelu Oy /ID# 235028, Kuopio

72211

Woodland International Research Group /ID# 236349, Little Rock

73112

Lynn Health Science Institute (LHSI) /ID# 237612, Oklahoma City

74136

Central States Research /ID# 238295, Tulsa

75093

AIM Trials /ID# 236366, Plano

77381

Family Psychiatry of The Woodlands /ID# 236423, The Woodlands

77546

Earle Research /ID# 236660, Friendswood

78229

Clinical Trials of Texas, Inc /ID# 237864, San Antonio

80910

MCB Clinical Research Centers /ID# 236927, Colorado Springs

90100

Oulu Mentalcare Oy /ID# 235089, Oulu

91403

Schuster Medical Research Institute /ID# 236445, Sherman Oaks

92054

North County Clinical Research /ID# 235014, Oceanside

92056

Excell Research, Inc /ID# 237717, Oceanside

92324

Axiom Research /ID# 236267, Colton

92627

Global Clinical Trials /ID# 235059, Costa Mesa

92705

Syrentis Clinical Research /ID# 237408, Santa Ana

92845

Collaborative Neuroscience Research - Orange County /ID# 237637, Garden Grove

92868

NRC Research Institute /ID# 234632, Orange

97301

Oregon Ctr for Clin Inv /ID# 237463, Salem

92804-3738

California Pharmaceutical Research Institute /ID# 236731, Anaheim

91206-4261

Behavioral Research Specialists, LLC /ID# 236622, Glendale

92251-9401

Sun Valley Research Center /ID# 236560, Imperial

92374-4555

Anderson Clinical Research /ID# 236624, Redlands

91403-2109

California Neuroscience Research Medical Group, Inc. /ID# 236636, Sherman Oaks

91786-3676

Pacific Clinical Research Management Group /ID# 234378, Upland

06416

CT Clinical Research /ID# 234638, Cromwell

32801-2986

Clinical Neuroscience Solutions, Inc /ID# 236604, Orlando

30082-2629

Iris Research Inc. /ID# 234995, Smyrna

02131-2515

Boston Clinical Trials /ID# 236558, Boston

02740

BTC of New Bedford /ID# 236381, New Bedford

02190

The Coastal Research Associates Inc /ID# 235056, South Weymouth

01103

Sisu at Renaissance Medical Group /ID# 236198, Springfield

08002-3008

Center for Emotional Fitness /ID# 236630, Cherry Hill

08755-6434

Bio Behavioral Health, Inc /ID# 238209, Toms River

11235-5660

SPRI Clinical Trails /ID# 236657, Brooklyn

10549-3028

Bioscience Research /ID# 234961, Mount Kisco

10017-1921

Fieve Clinical Research, Inc. /ID# 236632, New York

45215-2123

Patient Priority Clinical Sites, LLC /ID# 236743, Cincinnati

38119-5202

Research Strategies of Memphis /ID# 236629, Memphis

05091-9795

Woodstock Research Center /ID# 236653, Woodstock

N7L 1C1

Chatham-Kent Clinical Trials /ID# 235707, Chatham

K1C 1T1

Introspect Clinical Research Centre /ID# 235987, Ottawa

K1Z 1G3

Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890, Ottawa

J1L 0H8

Diex Recherche Sherbrooke Inc. /ID# 234385, Sherbrooke

160 00

Medical Services Prague /ID# 235109, Prague

602 00

Saint Anne s.r.o. /ID# 235060, Brno

615 00

MUDr. Marta Holanova /ID# 235126, Brno

503 41

Neuropsychiatriehk s.r.o. /ID# 236195, Hradec Králové

301 00

A-SHINE s.r.o. /ID# 236370, Pilsen

100 00

CLINTRIAL s.r.o. /ID# 237794, Prague

186 00

INEP medical s.r.o. /ID# 236291, Prague

00260

Helsingin psykiatripalvelu /ID# 235090, Helsinki

00270

Mederon Oy /ID# 235057, Helsinki

20-109

Centrum Medyczne Luxmed /ID# 235110, Lublin

80-546

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466, Gdansk

70-486

Zachodniopomorski Instytut Psychoterapii /ID# 236549, Szczecin

15-464

Wlokiennicza Med /ID# 235105, Bia?ystok

15-404

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065, Bialystok

85-080

Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197, Bydgoszcz

85-156

Med-Art /Id# 234986, Bydgoszcz

86-200

Poradnia Zdrowia Psychicznego /ID# 234750, Chełmno

25-411

Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064, Kielce

64-100

Nzop Mentis /Id# 235062, Leszno

20-831

Centrum Medyczne Neuromedica /ID# 235615, Lublin

41-200

Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061, Sosnowiec

87-100

Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001, Torun

Osrodek Badan Klinicznych Clinsante /ID# 234990, Torun

50-227

Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007, Wroclaw

97-400

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851, Bełchatów

00918

INSPIRA Clinical Research /ID# 234542, San Juan

811 07

J&J SMART Ltd. /ID# 235902, Bratislava

820 07

Psychiatrická ambulancia MENTUM /ID# 235020, Bratislava

851 01

Vavrusova Consulting s.r.o. /ID# 235022, Bratislava

040 01

EPAMED s.r.o. /ID# 234830, Košice

031 23

Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216, Liptovský Mikuláš

979 01

Psycholine s.r.o /ID# 235081, Rimavská Sobota

089 01

Centrum zdravia R.B.K sro /ID# 235085, Svidník

093 01

Crystal Comfort s.r.o. /ID# 235083, Vranov nad Topľou

Sponsors

Lead Sponsor

All Listed Sponsors
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INDUSTRY