Cariprazine Clinical Trials (2026): 44 Studies for Schizophrenia & Bipolar I Disorder
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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44 Cariprazine clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 17 indications (including Schizophrenia & Bipolar I Disorder) and 17,284 total planned enrollment. 22 Phase 3 Cariprazine trials and 11 Phase 2, 7 Phase 4 are listed. 6 Cariprazine clinical trials are actively recruiting at 35 U.S. sites across 12 states. Most recent activity: NCT07266545 (Dec 2030).
Where to Participate: All Cariprazine Trial Sites in the U.S. (35 sites across 12 states)
Every actively recruiting Cariprazinetrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CA | Advanced Research Center /ID# 227073 | Anaheim92805 | NCT04777357 | Map |
| CA | Inland Pyschiatric Medical Group - Chino /ID# 278667 | Chino91710 | NCT04777357 | Map |
| CA | Accellacare - Long Beach /ID# 279482 | Long Beach90807 | NCT04777357 | Map |
| CA | CHOC Children's Hospital /ID# 260298 | Orange92868-4203 | NCT04777357 | Map |
| CA | Inland Psychiatric Medical Group /ID# 274621 | Redlands92373 | NCT04777357 | Map |
| CA | University of California Davis Health /ID# 268306 | Sacramento95817 | NCT04777357 | Map |
| CA | Next Level Clinical Trials /ID# 277152 | West Covina91790 | NCT04777357 | Map |
| FL | D&H Doral Research Center-Doral /ID# 255458 | Doral33122 | NCT04777357 | Map |
| FL | Florida Research Center, Inc. /ID# 240775 | Miami33174 | NCT04777357 | Map |
| FL | G+C Research Group, LLC /ID# 261399 | Miami33126-2018 | NCT04777357 | Map |
| FL | Medical Research Group of Central Florida /ID# 256757 | Orange City32763 | NCT04777357 | Map |
| FL | Nova Psychiatry Inc. /ID# 270892 | Orlando32803 | NCT04777357 | Map |
| FL | D&H Tamarac Research Center /ID# 250434 | Tamarac33321-2979 | NCT04777357 | Map |
| GA | CenExcel iResearch LLC /ID# 228695 | Decatur30030 | NCT04777357 | Map |
| GA | Atlanta Behavioral Research, LLC /ID# 226486 | Dunwoody30338 | NCT04777357 | Map |
| GA | Denali Health Atlanta, LLC /ID# 278167 | Stone Mountain30083 | NCT04777357 | Map |
| IL | Advanced Quality Medical Research /ID# 272902 | Orland Park60462 | NCT04777357 | Map |
| MD | The Kennedy Krieger Institute /ID# 226509 | Baltimore21205 | NCT04777357 | Map |
| MN | Mayo Clinic in Rochester | Rochester55905 | NCT07266545 | Map |
| NJ | Med Clinical Research Partners LLC /ID# 240773 | Irvington07111 | NCT04777357 | Map |
| OH | Cleveland Clinic - Cleveland /ID# 276309 | Cleveland44195 | NCT04777357 | Map |
| OH | CincyScience /ID# 226318 | West Chester45069 | NCT04777357 | Map |
| OK | Sooner Clinical Research /ID# 226384 | Oklahoma City73116 | NCT04777357 | Map |
| TX | Beaumont Psychiatric Clinic /ID# 267484 | Beaumont77706 | NCT04777357 | Map |
| TX | Houston Clinical Trials - Bellaire /ID# 274189 | Bellaire77401 | NCT04777357 | Map |
| TX | Texas Research Group /ID# 270050 | Coppell75019 | NCT04777357 | Map |
| TX | Relaro Medical Trials /ID# 227156 | Dallas75243 | NCT04777357 | Map |
| TX | Earle Research /ID# 253782 | Friendswood77546 | NCT04777357 | Map |
| TX | Kaleidoscope Clinical Research /ID# 277650 | Houston77089 | NCT04777357 | Map |
| TX | Livingspring Family Medical Center /ID# 262706 | Mansfield76063-5622 | NCT04777357 | Map |
| TX | Aim Trials /ID# 226367 | Plano75093 | NCT04777357 | Map |
| TX | Perceptive Pharma Research /ID# 262219 | Richmond77407 | NCT04777357 | Map |
| TX | Family Psychiatry of The Woodlands /ID# 226290 | The Woodlands77381 | NCT04777357 | Map |
| UT | Pantheon Clinical Research /ID# 270879 | Bountiful84010 | NCT04777357 | Map |
| WA | Core Clinical Research /ID# 226374 | Everett98201 | NCT04777357 | Map |
Cariprazine clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|---|---|
| P1 | 3 | 3 | ||||||
| P1/P2 | 1 | 1 | ||||||
| P2 | 9 | 1 | 1 | 11 | ||||
| P3 | 2 | 16 | 3 | 1 | 22 | |||
| P4 | 2 | 1 | 1 | 1 | 1 | 1 | 7 |
Recruiting Cariprazine clinical trials (6)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07266545 | EDIT-ANDRERNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) | P4 | Unipolar Depression | 120 | Feb 2026 |
| NCT05933538 | Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder | P4 | Depressive Disorder, Major | 110 | Aug 2024 |
| NCT05913947 | DUAG9Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) | P4 | Depression, Bipolar | 122 | Dec 2022 |
| NCT07185815 | Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine | P1/P2 | Schizophrenia | 24 | Aug 2025 |
| NCT04777357 | 3112 Ped BPDA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | P3 | Depression | 380 | Apr 2021 |
| NCT03817502 | Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia | P3 | Schizophrenia | 330 | Jun 2019 |
Cariprazine clinical trials by indication
Schizophrenia (14)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07185815 | — | P1/P2 | recruiting | Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine |
| NCT03817502 | — | P3 | recruiting | Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia |
| NCT04578756 | 3070 Ped OLE | P3 | completed | Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder |
| NCT05368558 | 509 JPN Schz | P3 | terminated | Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia |
| NCT05168007 | — | P3 | unknown | Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia |
| NCT03593213 | — | P3 | terminated | Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia |
| NCT01412060 | — | P3 | completed | A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia |
| NCT01104792 | — | P3 | completed | Long-term Study of Cariprazine in Patients With Schizophrenia |
| + 6 more, see All trials below. | ||||
Major Depressive Disorder (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03738215 | ADT | P3 | completed | 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 | ADT | P3 | completed | 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 |
| NCT01715805 | ADT | P3 | completed | Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) |
| NCT01838876 | — | P3 | completed | Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder |
| NCT01469377 | — | P2 | completed | Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder |
| NCT00854100 | — | P2 | completed | Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder |
Bipolar I Disorder (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06433635 | SMART-BD | P4 | active not recruiting | Sequential Multiple Assignment Randomized Trial for Bipolar Depression |
| NCT04771299 | CARPZ-01 | P3 | terminated | Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients |
| NCT03573297 | — | P3 | completed | A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features |
| NCT01059539 | — | P3 | completed | Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder |
Bipolar Disorder (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02670538 | — | P3 | completed | Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder |
| NCT02670551 | — | P3 | completed | Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression |
| NCT01058096 | — | P3 | completed | Safety and Efficacy of Cariprazine for Mania |
| NCT00488618 | RGH-188 | P2 | completed | Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania |
Bipolar Depression (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05060549 | — | P4 | withdrawn | Dopamine D3 Receptor Occupancy in Bipolar Depression |
| NCT00852202 | — | P2 | completed | Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression |
Depression, Bipolar (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05913947 | DUAG9 | P4 | recruiting | Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) |
| NCT01396447 | — | P2 | completed | Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression |
Autism Spectrum Disorder (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05439616 | ASD | P3 | completed | Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD |
| NCT04382885 | — | P1 | completed | Cariprazine Pediatric ASD PK Study |
Unipolar Depression (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07266545 | EDIT-ANDRE | P4 | recruiting | RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) |
Depressive Disorder, Major (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05933538 | — | P4 | not yet recruiting | Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder |
Opioid-use Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05063201 | — | P2 | completed | Cariprazine for Comorbid Cocaine and Opioid Use Disorder |
Social Anxiety Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05384483 | — | P4 | completed | Cariprazine Versus Placebo for Social Anxiety Disorder |
Attention Deficit Hyperactivity Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04843423 | ADHD | P4 | unknown | Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder |
Generalized Anxiety Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04965272 | CAR aGAD Ph 2 | P2 | withdrawn | A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone |
Depression (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04777357 | 3112 Ped BPD | P3 | recruiting | A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. |
Cocaine Use Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03430544 | — | P2 | terminated | Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder |
Pharmacokinetic Profile (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02165098 | — | P1 | completed | Cariprazine: Comparison of Slow- and Immediate-release Forms |
Mania (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01058668 | — | P3 | completed | Safety and Efficacy of Cariprazine for Bipolar I Disorder |
Cariprazine pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| EDIT-ANDRE | NCT07266545 | P4 | recruiting | Unipolar Depression | 120 | — |
| SMART-BD | NCT06433635 | P4 | active not recruiting | Bipolar I Disorder | 2,726 | — |
| DUAG9 | NCT05913947 | P4 | recruiting | Depression, Bipolar | 122 | PMID 40866064 |
| ADHD | NCT04843423 | P4 | unknown | Attention Deficit Hyperactivity Disorder | 15 | — |
| 3112 Ped BPD | NCT04777357 | P3 | recruiting | Depression | 380 | — |
| 3070 Ped OLE | NCT04578756 | P3 | completed | Schizophrenia | 310 | — |
| ASD | NCT05439616 | P3 | completed | Autism Spectrum Disorder | 161 | — |
| 509 JPN Schz | NCT05368558 | P3 | terminated | Schizophrenia | 34 | — |
| CARPZ-01 | NCT04771299 | P3 | terminated | Bipolar I Disorder | 1 | — |
| ADT | NCT03738215 | P3 | completed | Major Depressive Disorder | 759 | PMID 36789515 |
| ADT | NCT03739203 | P3 | completed | Major Depressive Disorder | 752 | PMID 37585254 |
| ADT | NCT01715805 | P3 | completed | Major Depressive Disorder | 1,022 | — |
| CAR aGAD Ph 2 | NCT04965272 | P2 | withdrawn | Generalized Anxiety Disorder | 0 | — |
| RGH-188 | NCT00694707 | P2 | completed | Schizophrenia | 732 | PMID 30470662 |
| RGH-188 | NCT00488618 | P2 | completed | Bipolar Disorder | 238 | — |
Terminated and withdrawn Cariprazine trials (6)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05060549withdrawnDopamine D3 Receptor Occupancy in Bipolar Depression
- NCT05368558terminatedStudy to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
- NCT04771299terminatedAssessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients
- NCT04965272withdrawnA Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone
- NCT03593213terminatedClinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
- NCT03430544terminatedCariprazine Effects on Brain and Behavior in Cocaine Use Disorder
All Cariprazine trials (44)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07266545 | EDIT-ANDRE | RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) | P4 | recruiting | 120 | Mayo Clinic | Feb 2026 |
| NCT05933538 | Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder | P4 | not yet recruiting | 110 | Sultan Qaboos University | Aug 2024 | |
| NCT06433635 | SMART-BD | Sequential Multiple Assignment Randomized Trial for Bipolar Depression | P4 | active not recruiting | 2,726 | Massachusetts General Hospital | Oct 2024 |
| NCT05913947 | DUAG9 | Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) | P4 | recruiting | 122 | Aalborg University Hospital | Dec 2022 |
| NCT07185815 | Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine | P1/P2 | recruiting | 24 | Mapi Pharma Ltd. | Aug 2025 | |
| NCT05060549 | Dopamine D3 Receptor Occupancy in Bipolar Depression | P4 | withdrawn | 0 | New York State Psychiatric Institute | Jan 2026 | |
| NCT04777357 | 3112 Ped BPD | A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | P3 | recruiting | 380 | AbbVie | Apr 2021 |
| NCT03817502 | Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia | P3 | recruiting | 330 | Gedeon Richter Plc. | Jun 2019 | |
| NCT05063201 | Cariprazine for Comorbid Cocaine and Opioid Use Disorder | P2 | completed | 26 | Kyle Kampman | Aug 2022 | |
| NCT04578756 | 3070 Ped OLE | Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder | P3 | completed | 310 | AbbVie | Feb 2021 |
| NCT05439616 | ASD | Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD | P3 | completed | 161 | AbbVie | Jul 2022 |
| NCT05368558 | 509 JPN Schz | Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia | P3 | terminated | 34 | AbbVie | Aug 2022 |
| NCT04771299 | CARPZ-01 | Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients | P3 | terminated | 1 | Lakshmi N Yatham | Jul 2021 |
| NCT05384483 | Cariprazine Versus Placebo for Social Anxiety Disorder | P4 | completed | 40 | The Medical Research Network | Jul 2022 | |
| NCT05168007 | Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia | P3 | unknown | 342 | Whanin Pharmaceutical Company | Nov 2021 | |
| NCT04843423 | ADHD | Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder | P4 | unknown | 15 | Dr. Martin A. Katzman | Dec 2021 |
| NCT03573297 | A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features | P3 | completed | 901 | AbbVie | Jun 2018 | |
| NCT04382885 | Cariprazine Pediatric ASD PK Study | P1 | completed | 24 | AbbVie | Jun 2020 | |
| NCT03738215 | ADT | 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 | P3 | completed | 759 | AbbVie | Nov 2018 |
| NCT03739203 | ADT | 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 | P3 | completed | 752 | AbbVie | Nov 2018 |
| NCT04965272 | CAR aGAD Ph 2 | A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone | P2 | withdrawn | 0 | AbbVie | Aug 2021 |
| NCT03593213 | Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia | P3 | terminated | 587 | AbbVie | Jul 2018 | |
| NCT03430544 | Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder | P2 | terminated | 14 | Anna Rose Childress, Ph.D. | Apr 2018 | |
| NCT02670538 | Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder | P3 | completed | 493 | Forest Laboratories | Mar 2016 | |
| NCT02670551 | Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression | P3 | completed | 488 | Forest Laboratories | Mar 2016 | |
| NCT01715805 | ADT | Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) | P3 | completed | 1,022 | Forest Laboratories | Nov 2012 |
| NCT02165098 | Cariprazine: Comparison of Slow- and Immediate-release Forms | P1 | completed | 160 | Gedeon Richter Plc. | Jun 2014 | |
| NCT01838876 | Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder | P3 | completed | 442 | Forest Laboratories | Apr 2013 | |
| NCT01412060 | A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia | P3 | completed | 765 | Forest Laboratories | Sep 2011 | |
| NCT01396447 | Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression | P2 | completed | 584 | Forest Laboratories | Jul 2011 | |
| NCT01469377 | Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder | P2 | completed | 819 | Forest Laboratories | Dec 2011 | |
| NCT01104792 | Long-term Study of Cariprazine in Patients With Schizophrenia | P3 | completed | 752 | Forest Laboratories | May 2010 | |
| NCT01376076 | Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia | P1 | completed | 129 | Forest Laboratories | Jun 2011 | |
| NCT01059539 | Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder | P3 | completed | 403 | Forest Laboratories | Feb 2010 | |
| NCT01058668 | Safety and Efficacy of Cariprazine for Bipolar I Disorder | P3 | completed | 497 | Forest Laboratories | Feb 2010 | |
| NCT01104766 | Safety and Efficacy of Cariprazine in Patients With Schizophrenia | P3 | completed | 617 | Forest Laboratories | Apr 2010 | |
| NCT01104779 | Safety and Efficacy of Cariprazine in Schizophrenia | P3 | completed | 446 | Forest Laboratories | Apr 2010 | |
| NCT01058096 | Safety and Efficacy of Cariprazine for Mania | P3 | completed | 323 | Forest Laboratories | Feb 2010 | |
| NCT00854100 | Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder | P2 | completed | 231 | Forest Laboratories | Jun 2009 | |
| NCT00839852 | A Study of Cariprazine in Patients With Chronic Stable Schizophrenia | P2 | completed | 97 | Forest Laboratories | May 2009 | |
| NCT00852202 | Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression | P2 | completed | 234 | Forest Laboratories | Jun 2009 | |
| NCT00862992 | Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia | P2 | completed | 34 | Tanabe Pharma Corporation | Apr 2008 | |
| NCT00694707 | RGH-188 | Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia | P2 | completed | 732 | Forest Laboratories | Jun 2008 |
| NCT00488618 | RGH-188 | Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania | P2 | completed | 238 | Forest Laboratories | Jun 2007 |
Cariprazine clinical trials: frequently asked questions
- How many Cariprazine clinical trials are there?
- 44 Cariprazine clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 5 are actively recruiting participants. 29 are marked completed.
- Are Cariprazine clinical trials recruiting in 2026?
- Yes — 5 Cariprazine trials are actively recruiting in 2026, with 35 U.S. sites across 12 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Cariprazine being studied for?
- Cariprazine is being studied for Schizophrenia, Bipolar I Disorder, Major Depressive Disorder, Depression, Bipolar Disorder and 14 more. The trials are grouped by indication on this page.
- What phase is Cariprazine in?
- Cariprazine clinical trials span 7 Phase 4, 22 Phase 3, 11 Phase 2, 3 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Cariprazine clinical trials?
- The lead sponsor across the most Cariprazine trials is Forest Laboratories, with 15 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Cariprazineas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: