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

NCT ID: NCT03739203

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 752 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-10
• Study Completion Date: 2021-09-06

Brief Summary

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 MDD who have had an inadequate response to antidepressants alone.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo + ADT

Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo supplied in capsules

Antidepressant Therapy (ADT)

Intervention Type: DRUG

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

Cariprazine 1.5 mg/day + ADT

Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.

Group Type: EXPERIMENTAL

Cariprazine

Intervention Type: DRUG

Cariprazine supplied in capsules

Antidepressant Therapy (ADT)

Intervention Type: DRUG

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

Cariprazine 3 mg/day + ADT

Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.

Group Type: EXPERIMENTAL

Cariprazine

Intervention Type: DRUG

Cariprazine supplied in capsules

Antidepressant Therapy (ADT)

Intervention Type: DRUG

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

Interventions

Cariprazine

Cariprazine supplied in capsules

Intervention Type: DRUG

Placebo

Placebo supplied in capsules

Intervention Type: DRUG

Antidepressant Therapy (ADT)

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

Intervention Type: DRUG

Other Intervention Names

VRAYLAR®

Eligibility Criteria

Inclusion Criteria

• Written informed consent has been obtained.
• Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
• Participant must be an outpatient at the time of Visit 1 (Screening).
• Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD based on Structured Clinical Interview for DSM-5 (SCID-5), with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
• Diagnosis of MDD confirmed through a formal adjudication process.
• Participant demonstrates ability to follow study instructions and likely to complete all required visits.
• Participant must have an inadequate response, as measured by the modified antidepressant treatment response questionnaire (ATRQ), to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
• Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and Participants must agree to continue taking the same ADT dosing regimen through completion of Visit 6/early termination (ET). Participants who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
• Male and female Participants must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
• Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria

• Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
• Participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Harmonex /ID# 236936

Dothan, Alabama, United States

Woodland International Research Group /ID# 236349

Little Rock, Arkansas, United States

California Pharmaceutical Research Institute /ID# 236731

Anaheim, California, United States

Axiom Research /ID# 236267

Colton, California, United States

Global Clinical Trials /ID# 235059

Costa Mesa, California, United States

Collaborative Neuroscience Research - Orange County /ID# 237637

Garden Grove, California, United States

Behavioral Research Specialists, LLC /ID# 236622

Glendale, California, United States

Sun Valley Research Center /ID# 236560

Imperial, California, United States

North County Clinical Research /ID# 235014

Oceanside, California, United States

Excell Research, Inc /ID# 237717

Oceanside, California, United States

NRC Research Institute /ID# 234632

Orange, California, United States

Anderson Clinical Research /ID# 236624

Redlands, California, United States

Syrentis Clinical Research /ID# 237408

Santa Ana, California, United States

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

Sherman Oaks, California, United States

Schuster Medical Research Institute /ID# 236445

Sherman Oaks, California, United States

Pacific Clinical Research Management Group /ID# 234378

Upland, California, United States

MCB Clinical Research Centers /ID# 236927

Colorado Springs, Colorado, United States

CT Clinical Research /ID# 234638

Cromwell, Connecticut, United States

Innovative Clinical Research /ID# 235186

Fort Lauderdale, Florida, United States

Gulfcoast Clinical Research Center /ID# 236280

Fort Myers, Florida, United States

Innova Clinical Trials /ID# 237376

Miami, Florida, United States

International Research Associates, LLC /ID# 237410

Miami, Florida, United States

Medical Research Group of Central Florida /ID# 237326

Orange City, Florida, United States

Clinical Neuroscience Solutions, Inc /ID# 236604

Orlando, Florida, United States

Space Coast Neuropsychiatric Research Institute /ID# 235766

Palm Bay, Florida, United States

Atlanta Center for Medical Research /ID# 234696

Atlanta, Georgia, United States

Institute for Advanced Medical Research /ID# 234992

Atlanta, Georgia, United States

iResearch Savannah /ID# 236082

Savannah, Georgia, United States

Iris Research Inc. /ID# 234995

Smyrna, Georgia, United States

AMR Conventions Research /ID# 236262

Naperville, Illinois, United States

Collective Medical Research /ID# 236397

Prairie Village, Kansas, United States

Boston Clinical Trials /ID# 236558

Boston, Massachusetts, United States

BTC of New Bedford /ID# 236381

New Bedford, Massachusetts, United States

The Coastal Research Associates Inc /ID# 235056

South Weymouth, Massachusetts, United States

Sisu at Renaissance Medical Group /ID# 236198

Springfield, Massachusetts, United States

Center for Emotional Fitness /ID# 236630

Cherry Hill, New Jersey, United States

Bio Behavioral Health, Inc /ID# 238209

Toms River, New Jersey, United States

SPRI Clinical Trails /ID# 236657

Brooklyn, New York, United States

Bioscience Research /ID# 234961

Mount Kisco, New York, United States

Fieve Clinical Research, Inc. /ID# 236632

New York, New York, United States

Eastside Comprehensive Medical Center LLC /ID# 236094

New York, New York, United States

Clinical Trials America /ID# 237636

Hickory, North Carolina, United States

Quest Therapeutics of Avon Lake /ID# 236281

Avon Lake, Ohio, United States

Patient Priority Clinical Sites, LLC /ID# 236743

Cincinnati, Ohio, United States

North Star Medical Research LL /ID# 235076

Middleburg Heights, Ohio, United States

CincyScience /ID# 236387

West Chester, Ohio, United States

Lynn Health Science Institute (LHSI) /ID# 237612

Oklahoma City, Oklahoma, United States

Central States Research /ID# 238295

Tulsa, Oklahoma, United States

Oregon Ctr for Clin Inv /ID# 237463

Salem, Oregon, United States

Keystone Clinical Studies LLC /ID# 238153

Plymouth Meeting, Pennsylvania, United States

Psychiatric Consultants PC /ID# 235838

Franklin, Tennessee, United States

Research Strategies of Memphis /ID# 236629

Memphis, Tennessee, United States

Earle Research /ID# 236660

Friendswood, Texas, United States

AIM Trials /ID# 236366

Plano, Texas, United States

Clinical Trials of Texas, Inc /ID# 237864

San Antonio, Texas, United States

Family Psychiatry of The Woodlands /ID# 236423

The Woodlands, Texas, United States

Woodstock Research Center /ID# 236653

Woodstock, Vermont, United States

SSM Health Dean Medical Group /ID# 238103

Madison, Wisconsin, United States

Chatham-Kent Clinical Trials /ID# 235707

Chatham, Ontario, Canada

Introspect Clinical Research Centre /ID# 235987

Ottawa, Ontario, Canada

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

Ottawa, Ontario, Canada

Diex Recherche Sherbrooke Inc. /ID# 234385

Sherbrooke, Quebec, Canada

Medical Services Prague /ID# 235109

Prague, Praha, Hlavni Mesto, Czechia

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

Brno, , Czechia

MUDr. Marta Holanova /ID# 235126

Brno, , Czechia

Neuropsychiatriehk s.r.o. /ID# 236195

Hradec Králové, , Czechia

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

Pilsen, , Czechia

CLINTRIAL s.r.o. /ID# 237794

Prague, , Czechia

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

Prague, , Czechia

Helsingin psykiatripalvelu /ID# 235090

Helsinki, , Finland

Mederon Oy /ID# 235057

Helsinki, , Finland

Savon Psykiatripalvelu Oy /ID# 235028

Kuopio, , Finland

Oulu Mentalcare Oy /ID# 235089

Oulu, , Finland

Satakunnan Psykiatripalvelu Oy /ID# 234936

Rauma, , Finland

Psykiatri- ja psykologikeskus Mentoria /ID# 235091

Tampere, , Finland

Centrum Medyczne Luxmed /ID# 235110

Lublin, Lublin Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Zachodniopomorski Instytut Psychoterapii /ID# 236549

Szczecin, West Pomeranian Voivodeship, Poland

Wlokiennicza Med /ID# 235105

Bia?ystok, , Poland

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065

Bialystok, , Poland

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

Bydgoszcz, , Poland

Med-Art /Id# 234986

Bydgoszcz, , Poland

Poradnia Zdrowia Psychicznego /ID# 234750

Chełmno, , Poland

Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064

Kielce, , Poland

Nzop Mentis /Id# 235062

Leszno, , Poland

Centrum Medyczne Neuromedica /ID# 235615

Lublin, , Poland

Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061

Sosnowiec, , Poland

Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001

Torun, , Poland

Osrodek Badan Klinicznych Clinsante /ID# 234990

Torun, , Poland

Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007

Wroclaw, , Poland

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851

Bełchatów, Łódź Voivodeship, Poland

INSPIRA Clinical Research /ID# 234542

San Juan, , Puerto Rico

Military Medical Academy /ID# 237062

Belgrade, Beograd, Serbia

University Clinical Center Serbia /ID# 237747

Belgrade, Beograd, Serbia

University Clinical Center of Nis /ID# 236973

Niš, Nisavski Okrug, Serbia

University Clinical Center Kragujevac /ID# 237750

Kragujevac, Sumadijski Okrug, Serbia

University Clinical Center Kragujevac /ID# 237752

Kragujevac, Sumadijski Okrug, Serbia

University Clinical Center Kragujevac /ID# 237753

Kragujevac, Sumadijski Okrug, Serbia

Bel Medic - General Hospital /ID# 236171

Belgrade, , Serbia

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

Belgrade, , Serbia

Institute of Mental Health /ID# 236481

Belgrade, , Serbia

Special Hospital for Psychiatric Diseases Kovin /ID# 234691

Kovin, , Serbia

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716

Novi Kneževac, , Serbia

Special Psychiatric Hospital /ID# 235152

Vršac, , Serbia

J&J SMART Ltd. /ID# 235902

Bratislava, , Slovakia

Psychiatrická ambulancia MENTUM /ID# 235020

Bratislava, , Slovakia

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

Bratislava, , Slovakia

EPAMED s.r.o. /ID# 234830

Košice, , Slovakia

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

Liptovský Mikuláš, , Slovakia

Psycholine s.r.o /ID# 235081

Rimavská Sobota, , Slovakia

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

Svidník, , Slovakia

Crystal Comfort s.r.o. /ID# 235083

Vranov nad Topľou, , Slovakia

Countries

United States; Canada; Czechia; Finland; Poland; Puerto Rico; Serbia; Slovakia

References

Riesenberg R, Yeung PP, Rekeda L, Sachs GS, Kerolous M, Fava M. Cariprazine for the Adjunctive Treatment of Major Depressive Disorder in Patients With Inadequate Response to Antidepressant Therapy: Results of a Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2023 Aug 16;84(5):22m14643. doi: 10.4088/JCP.22m14643.

Reference Type: DERIVED

PMID: 37585254 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://rxabbvie.com

VRAYLAR® (cariprazine) capsules prescribing information.

Other Identifiers

2018-003164-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3111-302-001

Identifier Type: -

Identifier Source: org_study_id