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

NCT03739203 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 3111-302-0012018-003164-31
• Study Type: interventional
• Target: 752
• Locations: 8 countries
• Sites: 112

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

Keywords

MDD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score

  The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.

  Baseline and Week 6

Secondary Outcomes (1)

• Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score

  Baseline and Week 6

Study Arms (3)

Placebo + ADT

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Antidepressant Therapy (ADT)

Cariprazine 1.5 mg/day + ADT

EXPERIMENTAL

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.

Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)

Cariprazine 3 mg/day + ADT

EXPERIMENTAL

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.

Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)

Interventions

Cariprazine DRUG

Cariprazine supplied in capsules

Also known as: VRAYLAR®

Cariprazine 1.5 mg/day + ADT; Cariprazine 3 mg/day + ADT

Placebo DRUG

Placebo supplied in capsules

Placebo + ADT

Antidepressant Therapy (ADT) DRUG

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

Cariprazine 1.5 mg/day + ADT; Cariprazine 3 mg/day + ADT; Placebo + ADT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (112)

Harmonex /ID# 236936

Dothan, Alabama, 36303, United States

Location

Woodland International Research Group /ID# 236349

Little Rock, Arkansas, 72211, United States

Location

California Pharmaceutical Research Institute /ID# 236731

Anaheim, California, 92804-3738, United States

Location

Axiom Research /ID# 236267

Colton, California, 92324, United States

Location

Global Clinical Trials /ID# 235059

Costa Mesa, California, 92627, United States

Location

Collaborative Neuroscience Research - Orange County /ID# 237637

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists, LLC /ID# 236622

Glendale, California, 91206-4261, United States

Location

Sun Valley Research Center /ID# 236560

Imperial, California, 92251-9401, United States

Location

North County Clinical Research /ID# 235014

Oceanside, California, 92054, United States

Location

Excell Research, Inc /ID# 237717

Oceanside, California, 92056, United States

Location

NRC Research Institute /ID# 234632

Orange, California, 92868, United States

Location

Anderson Clinical Research /ID# 236624

Redlands, California, 92374-4555, United States

Location

Syrentis Clinical Research /ID# 237408

Santa Ana, California, 92705, United States

Location

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

Sherman Oaks, California, 91403-2109, United States

Location

Schuster Medical Research Institute /ID# 236445

Sherman Oaks, California, 91403, United States

Location

Pacific Clinical Research Management Group /ID# 234378

Upland, California, 91786-3676, United States

Location

MCB Clinical Research Centers /ID# 236927

Colorado Springs, Colorado, 80910, United States

Location

CT Clinical Research /ID# 234638

Cromwell, Connecticut, 06416, United States

Location

Innovative Clinical Research /ID# 235186

Fort Lauderdale, Florida, 33319, United States

Location

Gulfcoast Clinical Research Center /ID# 236280

Fort Myers, Florida, 33912, United States

Location

Innova Clinical Trials /ID# 237376

Miami, Florida, 33133, United States

Location

International Research Associates, LLC /ID# 237410

Miami, Florida, 33183, United States

Location

Medical Research Group of Central Florida /ID# 237326

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions, Inc /ID# 236604

Orlando, Florida, 32801-2986, United States

Location

Space Coast Neuropsychiatric Research Institute /ID# 235766

Palm Bay, Florida, 32905, United States

Location

Atlanta Center for Medical Research /ID# 234696

Atlanta, Georgia, 30331, United States

Location

Institute for Advanced Medical Research /ID# 234992

Atlanta, Georgia, 30341, United States

Location

iResearch Savannah /ID# 236082

Savannah, Georgia, 31405, United States

Location

Iris Research Inc. /ID# 234995

Smyrna, Georgia, 30082-2629, United States

Location

AMR Conventions Research /ID# 236262

Naperville, Illinois, 60563, United States

Location

Collective Medical Research /ID# 236397

Prairie Village, Kansas, 66208, United States

Location

Boston Clinical Trials /ID# 236558

Boston, Massachusetts, 02131-2515, United States

Location

BTC of New Bedford /ID# 236381

New Bedford, Massachusetts, 02740, United States

Location

The Coastal Research Associates Inc /ID# 235056

South Weymouth, Massachusetts, 02190, United States

Location

Sisu at Renaissance Medical Group /ID# 236198

Springfield, Massachusetts, 01103, United States

Location

Center for Emotional Fitness /ID# 236630

Cherry Hill, New Jersey, 08002-3008, United States

Location

Bio Behavioral Health, Inc /ID# 238209

Toms River, New Jersey, 08755-6434, United States

Location

SPRI Clinical Trails /ID# 236657

Brooklyn, New York, 11235-5660, United States

Location

Bioscience Research /ID# 234961

Mount Kisco, New York, 10549-3028, United States

Location

Fieve Clinical Research, Inc. /ID# 236632

New York, New York, 10017-1921, United States

Location

Eastside Comprehensive Medical Center LLC /ID# 236094

New York, New York, 10128, United States

Location

Clinical Trials America /ID# 237636

Hickory, North Carolina, 28601, United States

Location

Quest Therapeutics of Avon Lake /ID# 236281

Avon Lake, Ohio, 44012, United States

Location

Patient Priority Clinical Sites, LLC /ID# 236743

Cincinnati, Ohio, 45215-2123, United States

Location

North Star Medical Research LL /ID# 235076

Middleburg Heights, Ohio, 44130, United States

Location

CincyScience /ID# 236387

West Chester, Ohio, 45069, United States

Location

Lynn Health Science Institute (LHSI) /ID# 237612

Oklahoma City, Oklahoma, 73112, United States

Location

Central States Research /ID# 238295

Tulsa, Oklahoma, 74136, United States

Location

Oregon Ctr for Clin Inv /ID# 237463

Salem, Oregon, 97301, United States

Location

Keystone Clinical Studies LLC /ID# 238153

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Psychiatric Consultants PC /ID# 235838

Franklin, Tennessee, 37067, United States

Location

Research Strategies of Memphis /ID# 236629

Memphis, Tennessee, 38119-5202, United States

Location

Earle Research /ID# 236660

Friendswood, Texas, 77546, United States

Location

AIM Trials /ID# 236366

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, Inc /ID# 237864

San Antonio, Texas, 78229, United States

Location

Family Psychiatry of The Woodlands /ID# 236423

The Woodlands, Texas, 77381, United States

Location

Woodstock Research Center /ID# 236653

Woodstock, Vermont, 05091-9795, United States

Location

SSM Health Dean Medical Group /ID# 238103

Madison, Wisconsin, 53715, United States

Location

Chatham-Kent Clinical Trials /ID# 235707

Chatham, Ontario, N7L 1C1, Canada

Location

Introspect Clinical Research Centre /ID# 235987

Ottawa, Ontario, K1C 1T1, Canada

Location

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

Ottawa, Ontario, K1Z 1G3, Canada

Location

Diex Recherche Sherbrooke Inc. /ID# 234385

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Medical Services Prague /ID# 235109

Prague, Praha, Hlavni Mesto, 160 00, Czechia

Location

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

Brno, 602 00, Czechia

Location

MUDr. Marta Holanova /ID# 235126

Brno, 615 00, Czechia

Location

Neuropsychiatriehk s.r.o. /ID# 236195

Hradec Králové, 503 41, Czechia

Location

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

Pilsen, 301 00, Czechia

Location

CLINTRIAL s.r.o. /ID# 237794

Prague, 100 00, Czechia

Location

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

Prague, 186 00, Czechia

Location

Helsingin psykiatripalvelu /ID# 235090

Helsinki, 00260, Finland

Location

Mederon Oy /ID# 235057

Helsinki, 00270, Finland

Location

Savon Psykiatripalvelu Oy /ID# 235028

Kuopio, 70100, Finland

Location

Oulu Mentalcare Oy /ID# 235089

Oulu, 90100, Finland

Location

Satakunnan Psykiatripalvelu Oy /ID# 234936

Rauma, 26100, Finland

Location

Psykiatri- ja psykologikeskus Mentoria /ID# 235091

Tampere, 33200, Finland

Location

Centrum Medyczne Luxmed /ID# 235110

Lublin, Lublin Voivodeship, 20-109, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Zachodniopomorski Instytut Psychoterapii /ID# 236549

Szczecin, West Pomeranian Voivodeship, 70-486, Poland

Location

Wlokiennicza Med /ID# 235105

Bia?ystok, 15-464, Poland

Location

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065

Bialystok, 15-404, Poland

Location

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

Bydgoszcz, 85-080, Poland

Location

Med-Art /Id# 234986

Bydgoszcz, 85-156, Poland

Location

Poradnia Zdrowia Psychicznego /ID# 234750

Chełmno, 86-200, Poland

Location

Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064

Kielce, 25-411, Poland

Location

Nzop Mentis /Id# 235062

Leszno, 64-100, Poland

Location

Centrum Medyczne Neuromedica /ID# 235615

Lublin, 20-831, Poland

Location

Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061

Sosnowiec, 41-200, Poland

Location

Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001

Torun, 87-100, Poland

Location

Osrodek Badan Klinicznych Clinsante /ID# 234990

Torun, 87-100, Poland

Location

Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007

Wroclaw, 50-227, Poland

Location

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851

Bełchatów, Łódź Voivodeship, 97-400, Poland

Location

INSPIRA Clinical Research /ID# 234542

San Juan, 00918, Puerto Rico

Location

Military Medical Academy /ID# 237062

Belgrade, Beograd, 11000, Serbia

Location

University Clinical Center Serbia /ID# 237747

Belgrade, Beograd, 11000, Serbia

Location

University Clinical Center of Nis /ID# 236973

Niš, Nisavski Okrug, 18000, Serbia

Location

University Clinical Center Kragujevac /ID# 237750

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

University Clinical Center Kragujevac /ID# 237752

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

University Clinical Center Kragujevac /ID# 237753

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

Bel Medic - General Hospital /ID# 236171

Belgrade, 11000, Serbia

Location

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

Belgrade, 11040, Serbia

Location

Institute of Mental Health /ID# 236481

Belgrade, 11108, Serbia

Location

Special Hospital for Psychiatric Diseases Kovin /ID# 234691

Kovin, 26220, Serbia

Location

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716

Novi Kneževac, 23330, Serbia

Location

Special Psychiatric Hospital /ID# 235152

Vršac, 13000, Serbia

Location

J&J SMART Ltd. /ID# 235902

Bratislava, 811 07, Slovakia

Location

Psychiatrická ambulancia MENTUM /ID# 235020

Bratislava, 820 07, Slovakia

Location

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

Bratislava, 851 01, Slovakia

Location

EPAMED s.r.o. /ID# 234830

Košice, 040 01, Slovakia

Location

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

Liptovský Mikuláš, 031 23, Slovakia

Location

Psycholine s.r.o /ID# 235081

Rimavská Sobota, 979 01, Slovakia

Location

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

Svidník, 089 01, Slovakia

Location

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

Vranov nad Topľou, 093 01, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 37585254 DERIVED

Related Links

• VRAYLAR® (cariprazine) capsules prescribing information.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 13, 2018
• Study Start: November 10, 2018
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

FI (6); CZ (7); SE (12); PR (1); SL (8); CA (4); PL (16); US (58)