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AzTrials

Major Depressive DisorderPhase 3NCT03739203

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

A Phase 3 study testing Cariprazine and Antidepressant Therapy (ADT) in people with Major Depressive Disorder, run by AbbVie at 112 sites in 8 countries.

Completed

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

Official record
Search all trials

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 and Antidepressant Therapy (ADT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
752 participants
Where
112 sitesin 8 countries
Study dates
10 Nov 2018to 6 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]).
  • 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.
Show all 10Show fewer
  • 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.

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.
  • Participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

Trial locations and contacts

112 sites in 8 countries.

112 sites in 8 countries

United States58 sites

  • California Pharmaceutical Research Institute /ID# 236731

    Anaheim, California, 92804-3738

  • Atlanta Center for Medical Research /ID# 234696

    Atlanta, Georgia, 30331

  • Institute for Advanced Medical Research /ID# 234992

    Atlanta, Georgia, 30341

  • Quest Therapeutics of Avon Lake /ID# 236281

    Avon Lake, Ohio, 44012

  • Boston Clinical Trials /ID# 236558

    Boston, Massachusetts, 02131-2515

  • SPRI Clinical Trails /ID# 236657

    Brooklyn, New York, 11235-5660

  • Center for Emotional Fitness /ID# 236630

    Cherry Hill, New Jersey, 08002-3008

  • Patient Priority Clinical Sites, LLC /ID# 236743

    Cincinnati, Ohio, 45215-2123

  • MCB Clinical Research Centers /ID# 236927

    Colorado Springs, Colorado, 80910

  • Axiom Research /ID# 236267

    Colton, California, 92324

  • Global Clinical Trials /ID# 235059

    Costa Mesa, California, 92627

  • CT Clinical Research /ID# 234638

    Cromwell, Connecticut, 06416

  • Harmonex /ID# 236936

    Dothan, Alabama, 36303

  • Innovative Clinical Research /ID# 235186

    Fort Lauderdale, Florida, 33319

  • Gulfcoast Clinical Research Center /ID# 236280

    Fort Myers, Florida, 33912

  • Psychiatric Consultants PC /ID# 235838

    Franklin, Tennessee, 37067

  • Earle Research /ID# 236660

    Friendswood, Texas, 77546

  • Collaborative Neuroscience Research - Orange County /ID# 237637

    Garden Grove, California, 92845

  • Behavioral Research Specialists, LLC /ID# 236622

    Glendale, California, 91206-4261

  • Clinical Trials America /ID# 237636

    Hickory, North Carolina, 28601

  • Sun Valley Research Center /ID# 236560

    Imperial, California, 92251-9401

  • Woodland International Research Group /ID# 236349

    Little Rock, Arkansas, 72211

  • SSM Health Dean Medical Group /ID# 238103

    Madison, Wisconsin, 53715

  • Research Strategies of Memphis /ID# 236629

    Memphis, Tennessee, 38119-5202

  • Innova Clinical Trials /ID# 237376

    Miami, Florida, 33133

  • International Research Associates, LLC /ID# 237410

    Miami, Florida, 33183

  • North Star Medical Research LL /ID# 235076

    Middleburg Heights, Ohio, 44130

  • Bioscience Research /ID# 234961

    Mount Kisco, New York, 10549-3028

  • AMR Conventions Research /ID# 236262

    Naperville, Illinois, 60563

  • BTC of New Bedford /ID# 236381

    New Bedford, Massachusetts, 02740

  • Fieve Clinical Research, Inc. /ID# 236632

    New York, New York, 10017-1921

  • Eastside Comprehensive Medical Center LLC /ID# 236094

    New York, New York, 10128

  • North County Clinical Research /ID# 235014

    Oceanside, California, 92054

  • Excell Research, Inc /ID# 237717

    Oceanside, California, 92056

  • Lynn Health Science Institute (LHSI) /ID# 237612

    Oklahoma City, Oklahoma, 73112

  • NRC Research Institute /ID# 234632

    Orange, California, 92868

  • Medical Research Group of Central Florida /ID# 237326

    Orange City, Florida, 32763

  • Clinical Neuroscience Solutions, Inc /ID# 236604

    Orlando, Florida, 32801-2986

  • Space Coast Neuropsychiatric Research Institute /ID# 235766

    Palm Bay, Florida, 32905

  • AIM Trials /ID# 236366

    Plano, Texas, 75093

  • Keystone Clinical Studies LLC /ID# 238153

    Plymouth Meeting, Pennsylvania, 19462

  • Collective Medical Research /ID# 236397

    Prairie Village, Kansas, 66208

  • Anderson Clinical Research /ID# 236624

    Redlands, California, 92374-4555

  • Oregon Ctr for Clin Inv /ID# 237463

    Salem, Oregon, 97301

  • Clinical Trials of Texas, Inc /ID# 237864

    San Antonio, Texas, 78229

  • Syrentis Clinical Research /ID# 237408

    Santa Ana, California, 92705

  • iResearch Savannah /ID# 236082

    Savannah, Georgia, 31405

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

    Sherman Oaks, California, 91403-2109

  • Schuster Medical Research Institute /ID# 236445

    Sherman Oaks, California, 91403

  • Iris Research Inc. /ID# 234995

    Smyrna, Georgia, 30082-2629

  • The Coastal Research Associates Inc /ID# 235056

    South Weymouth, Massachusetts, 02190

  • Sisu at Renaissance Medical Group /ID# 236198

    Springfield, Massachusetts, 01103

  • Family Psychiatry of The Woodlands /ID# 236423

    The Woodlands, Texas, 77381

  • Bio Behavioral Health, Inc /ID# 238209

    Toms River, New Jersey, 08755-6434

  • Central States Research /ID# 238295

    Tulsa, Oklahoma, 74136

  • Pacific Clinical Research Management Group /ID# 234378

    Upland, California, 91786-3676

  • CincyScience /ID# 236387

    West Chester, Ohio, 45069

  • Woodstock Research Center /ID# 236653

    Woodstock, Vermont, 05091-9795

Other trials in United States

Poland16 sites

  • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851

    Bełchatów, Łódź Voivodeship, 97-400

  • Wlokiennicza Med /ID# 235105

    Bia?ystok, 15-464

  • MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065

    Bialystok, 15-404

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

    Bydgoszcz, 85-080

  • Med-Art /Id# 234986

    Bydgoszcz, 85-156

  • Poradnia Zdrowia Psychicznego /ID# 234750

    Chełmno, 86-200

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064

    Kielce, 25-411

  • Nzop Mentis /Id# 235062

    Leszno, 64-100

  • Centrum Medyczne Luxmed /ID# 235110

    Lublin, Lublin Voivodeship, 20-109

  • Centrum Medyczne Neuromedica /ID# 235615

    Lublin, 20-831

  • Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061

    Sosnowiec, 41-200

  • Zachodniopomorski Instytut Psychoterapii /ID# 236549

    Szczecin, West Pomeranian Voivodeship, 70-486

  • Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001

    Torun, 87-100

  • Osrodek Badan Klinicznych Clinsante /ID# 234990

    Torun, 87-100

  • Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007

    Wroclaw, 50-227

Other trials in Poland

Serbia12 sites

  • Military Medical Academy /ID# 237062

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 237747

    Belgrade, Beograd, 11000

  • Bel Medic - General Hospital /ID# 236171

    Belgrade, 11000

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

    Belgrade, 11040

  • Institute of Mental Health /ID# 236481

    Belgrade, 11108

  • Special Hospital for Psychiatric Diseases Kovin /ID# 234691

    Kovin, 26220

  • University Clinical Center Kragujevac /ID# 237750

    Kragujevac, Sumadijski Okrug, 34000

  • University Clinical Center Kragujevac /ID# 237752

    Kragujevac, Sumadijski Okrug, 34000

  • University Clinical Center Kragujevac /ID# 237753

    Kragujevac, Sumadijski Okrug, 34000

  • University Clinical Center of Nis /ID# 236973

    Niš, Nisavski Okrug, 18000

  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716

    Novi Kneževac, 23330

  • Special Psychiatric Hospital /ID# 235152

    Vršac, 13000

Other trials in Serbia

Slovakia8 sites

  • J&J SMART Ltd. /ID# 235902

    Bratislava, 811 07

  • Psychiatrická ambulancia MENTUM /ID# 235020

    Bratislava, 820 07

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

    Bratislava, 851 01

  • EPAMED s.r.o. /ID# 234830

    Košice, 040 01

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

    Liptovský Mikuláš, 031 23

  • Psycholine s.r.o /ID# 235081

    Rimavská Sobota, 979 01

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

    Svidník, 089 01

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

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Czechia7 sites

  • Saint Anne s.r.o. /ID# 235060

    Brno, 602 00

  • MUDr. Marta Holanova /ID# 235126

    Brno, 615 00

  • Neuropsychiatriehk s.r.o. /ID# 236195

    Hradec Králové, 503 41

  • A-SHINE s.r.o. /ID# 236370

    Pilsen, 301 00

  • Medical Services Prague /ID# 235109

    Prague, Praha, Hlavni Mesto, 160 00

  • CLINTRIAL s.r.o. /ID# 237794

    Prague, 100 00

  • INEP medical s.r.o. /ID# 236291

    Prague, 186 00

Other trials in Czechia

Finland6 sites

  • Helsingin psykiatripalvelu /ID# 235090

    Helsinki, 00260

  • Mederon Oy /ID# 235057

    Helsinki, 00270

  • Savon Psykiatripalvelu Oy /ID# 235028

    Kuopio, 70100

  • Oulu Mentalcare Oy /ID# 235089

    Oulu, 90100

  • Satakunnan Psykiatripalvelu Oy /ID# 234936

    Rauma, 26100

  • Psykiatri- ja psykologikeskus Mentoria /ID# 235091

    Tampere, 33200

Other trials in Finland

Canada4 sites

  • Chatham-Kent Clinical Trials /ID# 235707

    Chatham, Ontario, N7L 1C1

  • Introspect Clinical Research Centre /ID# 235987

    Ottawa, Ontario, K1C 1T1

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

    Ottawa, Ontario, K1Z 1G3

  • Diex Recherche Sherbrooke Inc. /ID# 234385

    Sherbrooke, Quebec, J1L 0H8

Other trials in Canada

Puerto Rico1 site

  • INSPIRA Clinical Research /ID# 234542

    San Juan, 00918

Other trials in Puerto Rico

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, Antidepressant Therapy (ADT)
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

    Also called VRAYLAR®

    Cariprazine supplied in capsules

  • PlaceboDrug

    Placebo supplied in capsules

  • Antidepressant Therapy (ADT)Drug

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

Study groups in NCT03739203
Study groupRoleWhat they receive
Placebo + ADTPlacebo comparatorCariprazine 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.
Receives: Drug: Placebo; Drug: Antidepressant Therapy (ADT)
Cariprazine 1.5 mg/day + ADTExperimentalCariprazine 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.
Receives: Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)
Cariprazine 3 mg/day + ADTExperimentalCariprazine 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.
Receives: Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)

What is being measured

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

  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.

    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 score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used 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 start10 Nov 2018
  3. Primary completion6 Sep 2021
  4. Study completion6 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
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739203
Sponsor's protocol ID
3111-302-001
Other IDs
2018-003164-31, 2018
Status last verified
Aug 2022
First submitted
9 Nov 2018
Last updated
21 Sep 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

  • 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.

    PubMed 37585254

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine and Antidepressant Therapy (ADT) in people with Major Depressive Disorder, run by AbbVie at 112 sites in 8 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Poland, Serbia, Slovakia, Czechia and 3 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 21 Sep 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?

Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score (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 NCT03739203, which also lists 1 linked publication.

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 21 Sep 2022.

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