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Major Depressive DisorderPhase 3NCT03738215

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

A Phase 3 study testing Cariprazine in people with Major Depressive Disorder, run by AbbVie at 125 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Cariprazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
759 participants
Where
125 sitesin 7 countries
Study dates
9 Nov 2018to 30 Sep 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

125 sites in 7 countries.

125 sites in 7 countries

United States65 sites

  • Lehigh Center for Clinical Research /ID# 236702

    Allentown, Pennsylvania, 18104-5034

  • Institute for Advanced Medical Research /ID# 236672

    Alpharetta, Georgia, 30022-1142

  • California Pharmaceutical Research Institute /ID# 236732

    Anaheim, California, 92804-3738

  • Advanced Research Center /ID# 237957

    Anaheim, California, 92805

  • Michigan Clinical Research Institute /ID# 234792

    Ann Arbor, Michigan, 48105-3205

  • Austin Clinical Trial Partners /ID# 236551

    Austin, Texas, 78737

  • BioBehavioral Research of Austin /ID# 236477

    Austin, Texas, 78759-5290

  • Quest Therapeutics of Avon Lake /ID# 236282

    Avon Lake, Ohio, 44012

  • Pharmasite Research, Inc. /ID# 237395

    Baltimore, Maryland, 21208

  • Houston Clinical Trials /ID# 234442

    Bellaire, Texas, 77401-2928

  • Northwest Clinical Research Center /ID# 237584

    Bellevue, Washington, 98007

  • Hassman Research Institute /ID# 237501

    Berlin, New Jersey, 08009

  • NeuroBehavioral Medicine Group /ID# 236671

    Bloomfield Hills, Michigan, 48302

  • Integrative Clinical Trials /ID# 236656

    Brooklyn, New York, 11229-3576

  • New Hope Clinical Research Inc. /ID# 234557

    Charlotte, North Carolina, 28211

  • CTI Clinical Trial and Consulting /ID# 236271

    Cincinnati, Ohio, 45212

  • Olympian Clinical Research /ID# 237417

    Clearwater, Florida, 33756

  • Axiom Research /ID# 236268

    Colton, California, 92324

  • The Ohio State University Department of Psychiatry /ID# 234583

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc /ID# 236619

    Costa Mesa, California, 92626-4607

  • ProScience Research Group /ID# 236442

    Culver City, California, 90230-6632

  • FutureSearch Trials of Dallas, LP /ID# 236275

    Dallas, Texas, 75231

  • iResearch Atlanta, LLC /ID# 237389

    Decatur, Georgia, 30030

  • Core Clinical Research /ID# 236405

    Everett, Washington, 98201

  • Precise Research Centers /ID# 236598

    Flowood, Mississippi, 39232-8839

  • Psychiatric Consultants PC /ID# 235839

    Franklin, Tennessee, 37067

  • Earle Research /ID# 236661

    Friendswood, Texas, 77546

  • CBH Health LLC /ID# 234536

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Research - Orange County /ID# 237639

    Garden Grove, California, 92845

  • MD Clinical

    Hallandale, Florida, 33009

  • Reliable Clinical Research /ID# 234786

    Hialeah, Florida, 33012-5830

  • Red Oak Psychiatry Associates /ID# 236600

    Houston, Texas, 77090-2641

  • Irvine Clinical Research /ID# 237409

    Irvine, California, 92614

  • CNS Healthcare - Jacksonville /ID# 238241

    Jacksonville, Florida, 32256-6039

  • Omega Clinical Trials LLC /ID# 238168

    La Habra, California, 90631-3842

  • Lake Charles Clinical Trials /ID# 237723

    Lake Charles, Louisiana, 70629

  • Altea Research Institute /ID# 236726

    Las Vegas, Nevada, 89102-1955

  • Synergy San Diego /ID# 236654

    Lemon Grove, California, 91945-2956

  • Capstone Clinical Research /ID# 236546

    Libertyville, Illinois, 60048-5341

  • Alivation Research /ID# 236583

    Lincoln, Nebraska, 68526-9474

  • Pillar Clinical Research /ID# 235702

    Lincolnwood, Illinois, 60712

  • Atria Clinical Research /ID# 237988

    Little Rock, Arkansas, 72209-7040

  • Psych Atlanta /ID# 235835

    Marietta, Georgia, 30060

  • Clinical Neuroscience Solutions - Memphis /ID# 237476

    Memphis, Tennessee, 38119

  • Manhattan Behavioral Medicine PLLC /ID# 236314

    New York, New York, 10036

  • Coastal Carolina Research Center /ID# 235909

    North Charleston, South Carolina, 29405

  • IPS Research Company /ID# 237671

    Oklahoma City, Oklahoma, 73106

  • Sooner Clinical Research /ID# 236346

    Oklahoma City, Oklahoma, 73112

  • Space Coast Neuropsychiatric Research Institute /ID# 235765

    Palm Bay, Florida, 32905

  • Alea Research /ID# 234789

    Phoenix, Arizona, 85012-2707

  • AIM Trials /ID# 236369

    Plano, Texas, 75093

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

    Portland, Oregon, 97214-2569

  • Richard Weisler MD, PA & Assoc /ID# 237424

    Raleigh, North Carolina, 27609

  • Anderson Clinical Research /ID# 236627

    Redlands, California, 92374-4555

  • Pillar Clinical Research LLC /ID# 234465

    Richardson, Texas, 75080

  • Finger Lakes Clinical Research /ID# 236578

    Rochester, New York, 14618-1609

  • Woodland Research Northwest, LLC /ID# 236641

    Rogers, Arkansas, 72758-6442

  • Sharp Mesa Vista Hospital /ID# 235797

    San Diego, California, 92123

  • J. Gary Booker MD APMC /ID# 234514

    Shreveport, Louisiana, 71104

  • Millennium Psychiatric Associates LLC /ID# 235989

    St Louis, Missouri, 63132

  • University of South Florida /ID# 234386

    Tampa, Florida, 33606

  • Viking Clinical Research /ID# 236614

    Temecula, California, 92591-6200

  • CincyScience /ID# 236391

    West Chester, Ohio, 45069

  • NeuroPsychiatric Research Practice & Associate LTD /ID# 234636

    Winfield, Illinois, 60190

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

    Woodstock, Vermont, 05091

Other trials in United States

Ukraine16 sites

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014

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

    Kharkiv, Kharkiv Oblast, 61068

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

    Kharkiv, Kharkiv Oblast, 61068

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

    Kharkiv, Kharkiv Oblast, 61068

  • Geikivka multidisciplinary hospital for psychiatric care /ID# 234498

    Kryvbas Village, Dnipropetrovsk Oblast, 53054

  • KNP Kyiv City Psychoneurological Hospital /ID# 235093

    Kyiv, 02192

  • Kyiv Railway Clinical Hosp No.2 /ID# 237405

    Kyiv, 03049

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

    Lviv, 79021

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

    Odesa, 65006

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

    Oleksandrivka Village, Odesa Oblast, 67513

  • Cherkasy regional psychiatric hospital of the CRC /ID# 234513

    Smila, Cherkasy Oblast, 20708

  • Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509

    Stepanivka Village, Kherson Oblast, 73488

  • Ternopil University Hospital /ID# 236819

    Ternopil, 46002

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

    Uzhhorod, Zakarpattia Oblast, 88000

  • Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178

    Vinnytsia, 21005

  • Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179

    Vinnytsia, 21005

Other trials in Ukraine

Bulgaria15 sites

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

    Kardzhali, 6600

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

    Kazanlak, 6100

  • UMHAT Dr Georgi Stranski EAD /ID# 237828

    Pleven, 5800

  • Medical Center Mentalcare OOD /ID# 234934

    Plovdiv, 4000

  • Clinic of Psychiatry /ID# 235878

    Plovdiv, 4002

  • Mental health Centre-Ruse EOOD /ID# 234775

    Rousse, 7003

  • Medical Center Sveti Naum EOOD /ID# 236069

    Sofia, 1113

  • Medical Center Hera EOOD /ID# 235859

    Sofia, 1510

  • Medical complex Doverie /ID# 238307

    Sofia, 1632

  • UMHAT Alexandrovska EAD /ID# 237834

    Sofiya, Sofia, 1431

  • Medical Centre - VAS OOD /ID# 235719

    Targovishte, 7700

  • Diagnostic consultative center Mladost M /ID# 236253

    Varna, 9020

  • Diagnostic consultative center Mladost M /ID# 236254

    Varna, 9020

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

    Veliko Tarnovo, 5000

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

    Vratsa, 3000

Other trials in Bulgaria

Hungary10 sites

  • Obudai Egeszsegugyi Centrum Kft. /ID# 237495

    Budapest, Pest County, 1036

  • Clinexpert Kft /ID# 237266

    Budapest, 1033

  • Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095

    Budapest, 1084

  • Semmelweis Egyetem /ID# 237096

    Budapest, 1085

  • Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912

    Budapest, 1135

  • Varoskapu Rendelo - Processus Kft. /ID# 235170

    Budapest, 1137

  • Bugat Pal Korhaz /ID# 238145

    Gyöngyös, Heves County, 3200

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

    Kalocsa, Bács-Kiskun county, 6300

  • PsychoTech Kft. /ID# 235008

    Pécs, Baranya, 7627

  • Szent Borbala Korhaz /ID# 238293

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

Germany8 sites

  • Private Practice - Dr. Thomsen /ID# 235713

    Berlin, 10245

  • Emovis GmbH /ID# 235010

    Berlin, 10629

  • MVZ LIO Berlin /ID# 235711

    Berlin, 12209

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

    Berlin, 13156

  • Arztpraxis Dr Kirsten Hahn /ID# 235958

    Berlin, 13187

  • Klinikum Chemnitz gGmbH /ID# 237758

    Chemnitz, 09116

  • Universitaetsklinikum Frankfurt /ID# 237292

    Frankfurt am Main, Hesse, 60590

  • Studienzentrum Nord-West /ID# 236357

    Westerstede, 26655

Other trials in Germany

United Kingdom7 sites

  • MAC Clinical Research /ID# 235938

    Blackpool, FY2 0JH

  • MAC Clinical Research /ID# 235941

    Blackpool, FY2 0JH

  • MAC Clinical Research /ID# 235945

    Blackpool, FY2 0JH

  • MAC Clinical Research /ID# 239078

    Blackpool, FY2 0JH

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

    Chertsey, Surrey, KT16 0AE

  • MAC Clinical Research-Manchester /ID# 235940

    Manchester, M13 9NQ

  • Knowle House Surgery /ID# 235025

    Plymouth, Devon, PL5 3JB

Other trials in United Kingdom

Estonia4 sites

  • West Tallinn Central Hospital /ID# 237078

    Tallinn, 10617

  • Marienthali Kliinik /ID# 235677

    Tallinn, 11315

  • Tartu University Hospital /ID# 237079

    Tartu, Tartu, 50406

  • OU Jaanson and Laane /ID# 234985

    Tartu, 50406

Other trials in Estonia

About this study

Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone

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.

Being tested
Cariprazine, Placebo
Keywords
MDD
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CariprazineDrug

    Cariprazine supplied in capsules

  • PlaceboDrug

    Placebo supplied in capsules

Study groups in NCT03738215
Study groupRoleWhat they receive
Cariprazine 1.5 mg/Day + ADTExperimentalDuring 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).
Receives: Drug: Cariprazine
Cariprazine 3 mg/Day + ADTExperimentalDuring 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).
Receives: Drug: Cariprazine
Placebo + ADTPlacebo comparatorDuring 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).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 6

Secondary outcomes (1)

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

    The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher scores indicate worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses. 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.

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start9 Nov 2018
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738215
Sponsor's protocol ID
3111-301-001
Other IDs
2018-002782-19, 2018
Status last verified
Sep 2022
First submitted
8 Nov 2018
Last updated
25 Oct 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Fava M, Masand PS, Maletic V, Chen C, Adams JL, Kerolous M. Efficacy of Adjunctive Cariprazine on Anxiety Symptoms in Patients With Major Depressive Disorder: Post Hoc Analysis of a Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2025 Apr 30;86(2):24m15506. doi: 10.4088/JCP.24m15506.

    PubMed 40315101

  • 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.

    PubMed 36789515

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Major Depressive Disorder, run by AbbVie at 125 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Ukraine, Bulgaria, Hungary, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03738215, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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