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

NCT03738215 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 3111-301-0012018-002782-19
• Study Type: interventional
• Target: 759
• Locations: 7 countries
• Sites: 125

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)

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

  The MADRS is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are 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 is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available 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)

Cariprazine 1.5 mg/Day + ADT

EXPERIMENTAL

During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).

Drug: Cariprazine

Cariprazine 3 mg/Day + ADT

EXPERIMENTAL

During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).

Drug: Cariprazine

Placebo + ADT

PLACEBO COMPARATOR

During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).

Drug: Placebo

Interventions

Cariprazine DRUG

Cariprazine supplied in capsules

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

Placebo DRUG

Placebo supplied in capsules

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 \[EU sites\]).
• Patient must be an outpatient at the time of Visit 1 (Screening).
• Patient meets the DSM-5 criteria for MDD based on 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.
• Patient demonstrates ability to follow study instructions and likely to complete all required visits.
• Patient must have an inadequate response, as measured by the modified 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 patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients 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 patients 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.
• Patient 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 (125)

Alea Research /ID# 234789

Phoenix, Arizona, 85012-2707, United States

Location

Atria Clinical Research /ID# 237988

Little Rock, Arkansas, 72209-7040, United States

Location

Woodland Research Northwest, LLC /ID# 236641

Rogers, Arkansas, 72758-6442, United States

Location

California Pharmaceutical Research Institute /ID# 236732

Anaheim, California, 92804-3738, United States

Location

Advanced Research Center /ID# 237957

Anaheim, California, 92805, United States

Location

Axiom Research /ID# 236268

Colton, California, 92324, United States

Location

ATP Clinical Research, Inc /ID# 236619

Costa Mesa, California, 92626-4607, United States

Location

ProScience Research Group /ID# 236442

Culver City, California, 90230-6632, United States

Location

Collaborative Neuroscience Research - Orange County /ID# 237639

Garden Grove, California, 92845, United States

Location

Irvine Clinical Research /ID# 237409

Irvine, California, 92614, United States

Location

Omega Clinical Trials LLC /ID# 238168

La Habra, California, 90631-3842, United States

Location

Synergy San Diego /ID# 236654

Lemon Grove, California, 91945-2956, United States

Location

Anderson Clinical Research /ID# 236627

Redlands, California, 92374-4555, United States

Location

Sharp Mesa Vista Hospital /ID# 235797

San Diego, California, 92123, United States

Location

Viking Clinical Research /ID# 236614

Temecula, California, 92591-6200, United States

Location

Olympian Clinical Research /ID# 237417

Clearwater, Florida, 33756, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Reliable Clinical Research /ID# 234786

Hialeah, Florida, 33012-5830, United States

Location

CNS Healthcare - Jacksonville /ID# 238241

Jacksonville, Florida, 32256-6039, United States

Location

Space Coast Neuropsychiatric Research Institute /ID# 235765

Palm Bay, Florida, 32905, United States

Location

University of South Florida /ID# 234386

Tampa, Florida, 33606, United States

Location

Institute for Advanced Medical Research /ID# 236672

Alpharetta, Georgia, 30022-1142, United States

Location

iResearch Atlanta, LLC /ID# 237389

Decatur, Georgia, 30030, United States

Location

Psych Atlanta /ID# 235835

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research /ID# 236546

Libertyville, Illinois, 60048-5341, United States

Location

Pillar Clinical Research /ID# 235702

Lincolnwood, Illinois, 60712, United States

Location

NeuroPsychiatric Research Practice & Associate LTD /ID# 234636

Winfield, Illinois, 60190, United States

Location

Lake Charles Clinical Trials /ID# 237723

Lake Charles, Louisiana, 70629, United States

Location

J. Gary Booker MD APMC /ID# 234514

Shreveport, Louisiana, 71104, United States

Location

Pharmasite Research, Inc. /ID# 237395

Baltimore, Maryland, 21208, United States

Location

CBH Health LLC /ID# 234536

Gaithersburg, Maryland, 20877, United States

Location

Michigan Clinical Research Institute /ID# 234792

Ann Arbor, Michigan, 48105-3205, United States

Location

NeuroBehavioral Medicine Group /ID# 236671

Bloomfield Hills, Michigan, 48302, United States

Location

Precise Research Centers /ID# 236598

Flowood, Mississippi, 39232-8839, United States

Location

Millennium Psychiatric Associates LLC /ID# 235989

St Louis, Missouri, 63132, United States

Location

Alivation Research /ID# 236583

Lincoln, Nebraska, 68526-9474, United States

Location

Altea Research Institute /ID# 236726

Las Vegas, Nevada, 89102-1955, United States

Location

Hassman Research Institute /ID# 237501

Berlin, New Jersey, 08009, United States

Location

Integrative Clinical Trials /ID# 236656

Brooklyn, New York, 11229-3576, United States

Location

Manhattan Behavioral Medicine PLLC /ID# 236314

New York, New York, 10036, United States

Location

Finger Lakes Clinical Research /ID# 236578

Rochester, New York, 14618-1609, United States

Location

New Hope Clinical Research Inc. /ID# 234557

Charlotte, North Carolina, 28211, United States

Location

Richard Weisler MD, PA & Assoc /ID# 237424

Raleigh, North Carolina, 27609, United States

Location

Quest Therapeutics of Avon Lake /ID# 236282

Avon Lake, Ohio, 44012, United States

Location

CTI Clinical Trial and Consulting /ID# 236271

Cincinnati, Ohio, 45212, United States

Location

The Ohio State University Department of Psychiatry /ID# 234583

Columbus, Ohio, 43210, United States

Location

CincyScience /ID# 236391

West Chester, Ohio, 45069, United States

Location

IPS Research Company /ID# 237671

Oklahoma City, Oklahoma, 73106, United States

Location

Sooner Clinical Research /ID# 236346

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649

Portland, Oregon, 97214-2569, United States

Location

Lehigh Center for Clinical Research /ID# 236702

Allentown, Pennsylvania, 18104-5034, United States

Location

Coastal Carolina Research Center /ID# 235909

North Charleston, South Carolina, 29405, United States

Location

Psychiatric Consultants PC /ID# 235839

Franklin, Tennessee, 37067, United States

Location

Clinical Neuroscience Solutions - Memphis /ID# 237476

Memphis, Tennessee, 38119, United States

Location

Austin Clinical Trial Partners /ID# 236551

Austin, Texas, 78737, United States

Location

BioBehavioral Research of Austin /ID# 236477

Austin, Texas, 78759-5290, United States

Location

Houston Clinical Trials /ID# 234442

Bellaire, Texas, 77401-2928, United States

Location

FutureSearch Trials of Dallas, LP /ID# 236275

Dallas, Texas, 75231, United States

Location

Earle Research /ID# 236661

Friendswood, Texas, 77546, United States

Location

Red Oak Psychiatry Associates /ID# 236600

Houston, Texas, 77090-2641, United States

Location

AIM Trials /ID# 236369

Plano, Texas, 75093, United States

Location

Pillar Clinical Research LLC /ID# 234465

Richardson, Texas, 75080, United States

Location

Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087

Woodstock, Vermont, 05091, United States

Location

Northwest Clinical Research Center /ID# 237584

Bellevue, Washington, 98007, United States

Location

Core Clinical Research /ID# 236405

Everett, Washington, 98201, United States

Location

UMHAT Alexandrovska EAD /ID# 237834

Sofiya, Sofia, 1431, Bulgaria

Location

State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625

Kardzhali, 6600, Bulgaria

Location

MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773

Kazanlak, 6100, Bulgaria

Location

UMHAT Dr Georgi Stranski EAD /ID# 237828

Pleven, 5800, Bulgaria

Location

Medical Center Mentalcare OOD /ID# 234934

Plovdiv, 4000, Bulgaria

Location

Clinic of Psychiatry /ID# 235878

Plovdiv, 4002, Bulgaria

Location

Mental health Centre-Ruse EOOD /ID# 234775

Rousse, 7003, Bulgaria

Location

Medical Center Sveti Naum EOOD /ID# 236069

Sofia, 1113, Bulgaria

Location

Medical Center Hera EOOD /ID# 235859

Sofia, 1510, Bulgaria

Location

Medical complex Doverie /ID# 238307

Sofia, 1632, Bulgaria

Location

Medical Centre - VAS OOD /ID# 235719

Targovishte, 7700, Bulgaria

Location

Diagnostic consultative center Mladost M /ID# 236253

Varna, 9020, Bulgaria

Location

Diagnostic consultative center Mladost M /ID# 236254

Varna, 9020, Bulgaria

Location

Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078

Veliko Tarnovo, 5000, Bulgaria

Location

Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960

Vratsa, 3000, Bulgaria

Location

Tartu University Hospital /ID# 237079

Tartu, Tartu, 50406, Estonia

Location

West Tallinn Central Hospital /ID# 237078

Tallinn, 10617, Estonia

Location

Marienthali Kliinik /ID# 235677

Tallinn, 11315, Estonia

Location

OU Jaanson and Laane /ID# 234985

Tartu, 50406, Estonia

Location

Universitaetsklinikum Frankfurt /ID# 237292

Frankfurt am Main, Hesse, 60590, Germany

Location

Private Practice - Dr. Thomsen /ID# 235713

Berlin, 10245, Germany

Location

Emovis GmbH /ID# 235010

Berlin, 10629, Germany

Location

MVZ LIO Berlin /ID# 235711

Berlin, 12209, Germany

Location

BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970

Berlin, 13156, Germany

Location

Arztpraxis Dr Kirsten Hahn /ID# 235958

Berlin, 13187, Germany

Location

Klinikum Chemnitz gGmbH /ID# 237758

Chemnitz, 09116, Germany

Location

Studienzentrum Nord-West /ID# 236357

Westerstede, 26655, Germany

Location

PsychoTech Kft. /ID# 235008

Pécs, Baranya, 7627, Hungary

Location

Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974

Kalocsa, Bács-Kiskun county, 6300, Hungary

Location

Bugat Pal Korhaz /ID# 238145

Gyöngyös, Heves County, 3200, Hungary

Location

Szent Borbala Korhaz /ID# 238293

Tatabánya, Komárom-Esztergom, 2800, Hungary

Location

Obudai Egeszsegugyi Centrum Kft. /ID# 237495

Budapest, Pest County, 1036, Hungary

Location

Clinexpert Kft /ID# 237266

Budapest, 1033, Hungary

Location

Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095

Budapest, 1084, Hungary

Location

Semmelweis Egyetem /ID# 237096

Budapest, 1085, Hungary

Location

Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912

Budapest, 1135, Hungary

Location

Varoskapu Rendelo - Processus Kft. /ID# 235170

Budapest, 1137, Hungary

Location

Cherkasy regional psychiatric hospital of the CRC /ID# 234513

Smila, Cherkasy Oblast, 20708, Ukraine

Location

Geikivka multidisciplinary hospital for psychiatric care /ID# 234498

Kryvbas Village, Dnipropetrovsk Oblast, 53054, Ukraine

Location

KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014, Ukraine

Location

SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509

Stepanivka Village, Kherson Oblast, 73488, Ukraine

Location

Odesa regional psychiatric hospital 2 of the ORC /ID# 234505

Oleksandrivka Village, Odesa Oblast, 67513, Ukraine

Location

KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

Location

KNP Kyiv City Psychoneurological Hospital /ID# 235093

Kyiv, 02192, Ukraine

Location

Kyiv Railway Clinical Hosp No.2 /ID# 237405

Kyiv, 03049, Ukraine

Location

CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270

Lviv, 79021, Ukraine

Location

MNCE Odesa Regional Medical Center for Mental Health /ID# 235723

Odesa, 65006, Ukraine

Location

Ternopil University Hospital /ID# 236819

Ternopil, 46002, Ukraine

Location

Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178

Vinnytsia, 21005, Ukraine

Location

Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179

Vinnytsia, 21005, Ukraine

Location

Knowle House Surgery /ID# 235025

Plymouth, Devon, PL5 3JB, United Kingdom

Location

St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725

Chertsey, Surrey, KT16 0AE, United Kingdom

Location

MAC Clinical Research /ID# 235938

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research /ID# 235941

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research /ID# 235945

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research /ID# 239078

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research-Manchester /ID# 235940

Manchester, M13 9NQ, United Kingdom

Location

Related Publications (1)

• Sachs GS, Yeung PP, Rekeda L, Khan A, Adams JL, Fava M. Adjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2023 Mar 1;180(3):241-251. doi: 10.1176/appi.ajp.20220504. Epub 2023 Feb 15.

  PMID: 36789515 DERIVED

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
• Restrictive Agreement: No

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 8, 2018
• First Posted: November 13, 2018
• Study Start: November 9, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2022-09

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

GB (7); US (65); BU (15); DE (8); HU (10); ES (4); UA (16)