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.

StateFacilityCityTrialMap
CAAdvanced Research Center /ID# 227073Anaheim92805NCT04777357Map
CAInland Pyschiatric Medical Group - Chino /ID# 278667Chino91710NCT04777357Map
CAAccellacare - Long Beach /ID# 279482Long Beach90807NCT04777357Map
CACHOC Children's Hospital /ID# 260298Orange92868-4203NCT04777357Map
CAInland Psychiatric Medical Group /ID# 274621Redlands92373NCT04777357Map
CAUniversity of California Davis Health /ID# 268306Sacramento95817NCT04777357Map
CANext Level Clinical Trials /ID# 277152West Covina91790NCT04777357Map
FLD&H Doral Research Center-Doral /ID# 255458Doral33122NCT04777357Map
FLFlorida Research Center, Inc. /ID# 240775Miami33174NCT04777357Map
FLG+C Research Group, LLC /ID# 261399Miami33126-2018NCT04777357Map
FLMedical Research Group of Central Florida /ID# 256757Orange City32763NCT04777357Map
FLNova Psychiatry Inc. /ID# 270892Orlando32803NCT04777357Map
FLD&H Tamarac Research Center /ID# 250434Tamarac33321-2979NCT04777357Map
GACenExcel iResearch LLC /ID# 228695Decatur30030NCT04777357Map
GAAtlanta Behavioral Research, LLC /ID# 226486Dunwoody30338NCT04777357Map
GADenali Health Atlanta, LLC /ID# 278167Stone Mountain30083NCT04777357Map
ILAdvanced Quality Medical Research /ID# 272902Orland Park60462NCT04777357Map
MDThe Kennedy Krieger Institute /ID# 226509Baltimore21205NCT04777357Map
MNMayo Clinic in RochesterRochester55905NCT07266545Map
NJMed Clinical Research Partners LLC /ID# 240773Irvington07111NCT04777357Map
OHCleveland Clinic - Cleveland /ID# 276309Cleveland44195NCT04777357Map
OHCincyScience /ID# 226318West Chester45069NCT04777357Map
OKSooner Clinical Research /ID# 226384Oklahoma City73116NCT04777357Map
TXBeaumont Psychiatric Clinic /ID# 267484Beaumont77706NCT04777357Map
TXHouston Clinical Trials - Bellaire /ID# 274189Bellaire77401NCT04777357Map
TXTexas Research Group /ID# 270050Coppell75019NCT04777357Map
TXRelaro Medical Trials /ID# 227156Dallas75243NCT04777357Map
TXEarle Research /ID# 253782Friendswood77546NCT04777357Map
TXKaleidoscope Clinical Research /ID# 277650Houston77089NCT04777357Map
TXLivingspring Family Medical Center /ID# 262706Mansfield76063-5622NCT04777357Map
TXAim Trials /ID# 226367Plano75093NCT04777357Map
TXPerceptive Pharma Research /ID# 262219Richmond77407NCT04777357Map
TXFamily Psychiatry of The Woodlands /ID# 226290The Woodlands77381NCT04777357Map
UTPantheon Clinical Research /ID# 270879Bountiful84010NCT04777357Map
WACore Clinical Research /ID# 226374Everett98201NCT04777357Map

Cariprazine clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedterminatedwithdrawnnot yet recruitingunknownTotal
P133
P1/P211
P291111
P32163122
P42111117

Recruiting Cariprazine clinical trials (6)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07266545EDIT-ANDRERNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)P4Unipolar Depression120Feb 2026
NCT05933538Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive DisorderP4Depressive Disorder, Major110Aug 2024
NCT05913947DUAG9Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)P4Depression, Bipolar122Dec 2022
NCT07185815Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral CariprazineP1/P2Schizophrenia24Aug 2025
NCT047773573112 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.P3Depression380Apr 2021
NCT03817502Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With SchizophreniaP3Schizophrenia330Jun 2019

Cariprazine clinical trials by indication

Schizophrenia (14)

NCTAcronymPhaseStatusTitle
NCT07185815P1/P2recruitingPharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
NCT03817502P3recruitingEfficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
NCT045787563070 Ped OLEP3completedOpen-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
NCT05368558509 JPN SchzP3terminatedStudy to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
NCT05168007P3unknownStudy Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
NCT03593213P3terminatedClinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
NCT01412060P3completedA Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
NCT01104792P3completedLong-term Study of Cariprazine in Patients With Schizophrenia
+ 6 more, see All trials below.

Major Depressive Disorder (6)

NCTAcronymPhaseStatusTitle
NCT03738215ADTP3completedEfficacy, 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
NCT03739203ADTP3completedThe 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
NCT01715805ADTP3completedEfficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
NCT01838876P3completedLong-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
NCT01469377P2completedSafety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
NCT00854100P2completedSafety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

Bipolar I Disorder (4)

NCTAcronymPhaseStatusTitle
NCT06433635SMART-BDP4active not recruitingSequential Multiple Assignment Randomized Trial for Bipolar Depression
NCT04771299CARPZ-01P3terminatedAssessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients
NCT03573297P3completedA Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
NCT01059539P3completedLong-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Bipolar Disorder (4)

NCTAcronymPhaseStatusTitle
NCT02670538P3completedStudy 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
NCT02670551P3completedStudy on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
NCT01058096P3completedSafety and Efficacy of Cariprazine for Mania
NCT00488618RGH-188P2completedStudy Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

Bipolar Depression (2)

NCTAcronymPhaseStatusTitle
NCT05060549P4withdrawnDopamine D3 Receptor Occupancy in Bipolar Depression
NCT00852202P2completedSafety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Depression, Bipolar (2)

NCTAcronymPhaseStatusTitle
NCT05913947DUAG9P4recruitingLithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
NCT01396447P2completedSafety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Autism Spectrum Disorder (2)

NCTAcronymPhaseStatusTitle
NCT05439616ASDP3completedStudy 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
NCT04382885P1completedCariprazine Pediatric ASD PK Study

Unipolar Depression (1)

NCTAcronymPhaseStatusTitle
NCT07266545EDIT-ANDREP4recruitingRNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Depressive Disorder, Major (1)

NCTAcronymPhaseStatusTitle
NCT05933538P4not yet recruitingEffectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

Opioid-use Disorder (1)

NCTAcronymPhaseStatusTitle
NCT05063201P2completedCariprazine for Comorbid Cocaine and Opioid Use Disorder

Social Anxiety Disorder (1)

NCTAcronymPhaseStatusTitle
NCT05384483P4completedCariprazine Versus Placebo for Social Anxiety Disorder

Attention Deficit Hyperactivity Disorder (1)

NCTAcronymPhaseStatusTitle
NCT04843423ADHDP4unknownAdjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder

Generalized Anxiety Disorder (1)

NCTAcronymPhaseStatusTitle
NCT04965272CAR aGAD Ph 2P2withdrawnA 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)

NCTAcronymPhaseStatusTitle
NCT047773573112 Ped BPDP3recruitingA 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)

NCTAcronymPhaseStatusTitle
NCT03430544P2terminatedCariprazine Effects on Brain and Behavior in Cocaine Use Disorder

Pharmacokinetic Profile (1)

NCTAcronymPhaseStatusTitle
NCT02165098P1completedCariprazine: Comparison of Slow- and Immediate-release Forms

Mania (1)

NCTAcronymPhaseStatusTitle
NCT01058668P3completedSafety 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
EDIT-ANDRENCT07266545P4recruitingUnipolar Depression120
SMART-BDNCT06433635P4active not recruitingBipolar I Disorder2,726
DUAG9NCT05913947P4recruitingDepression, Bipolar122PMID 40866064
ADHDNCT04843423P4unknownAttention Deficit Hyperactivity Disorder15
3112 Ped BPDNCT04777357P3recruitingDepression380
3070 Ped OLENCT04578756P3completedSchizophrenia310
ASDNCT05439616P3completedAutism Spectrum Disorder161
509 JPN SchzNCT05368558P3terminatedSchizophrenia34
CARPZ-01NCT04771299P3terminatedBipolar I Disorder1
ADTNCT03738215P3completedMajor Depressive Disorder759PMID 36789515
ADTNCT03739203P3completedMajor Depressive Disorder752PMID 37585254
ADTNCT01715805P3completedMajor Depressive Disorder1,022
CAR aGAD Ph 2NCT04965272P2withdrawnGeneralized Anxiety Disorder0
RGH-188NCT00694707P2completedSchizophrenia732PMID 30470662
RGH-188NCT00488618P2completedBipolar Disorder238

Terminated and withdrawn Cariprazine trials (6)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT07266545EDIT-ANDRERNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)P4recruiting120Mayo ClinicFeb 2026
NCT05933538Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive DisorderP4not yet recruiting110Sultan Qaboos UniversityAug 2024
NCT06433635SMART-BDSequential Multiple Assignment Randomized Trial for Bipolar DepressionP4active not recruiting2,726Massachusetts General HospitalOct 2024
NCT05913947DUAG9Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)P4recruiting122Aalborg University HospitalDec 2022
NCT07185815Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral CariprazineP1/P2recruiting24Mapi Pharma Ltd.Aug 2025
NCT05060549Dopamine D3 Receptor Occupancy in Bipolar DepressionP4withdrawn0New York State Psychiatric InstituteJan 2026
NCT047773573112 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.P3recruiting380AbbVieApr 2021
NCT03817502Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With SchizophreniaP3recruiting330Gedeon Richter Plc.Jun 2019
NCT05063201Cariprazine for Comorbid Cocaine and Opioid Use DisorderP2completed26Kyle KampmanAug 2022
NCT045787563070 Ped OLEOpen-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 DisorderP3completed310AbbVieFeb 2021
NCT05439616ASDStudy 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 ASDP3completed161AbbVieJul 2022
NCT05368558509 JPN SchzStudy to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With SchizophreniaP3terminated34AbbVieAug 2022
NCT04771299CARPZ-01Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar PatientsP3terminated1Lakshmi N YathamJul 2021
NCT05384483Cariprazine Versus Placebo for Social Anxiety DisorderP4completed40The Medical Research NetworkJul 2022
NCT05168007Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With SchizophreniaP3unknown342Whanin Pharmaceutical CompanyNov 2021
NCT04843423ADHDAdjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity DisorderP4unknown15Dr. Martin A. KatzmanDec 2021
NCT03573297A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed FeaturesP3completed901AbbVieJun 2018
NCT04382885Cariprazine Pediatric ASD PK StudyP1completed24AbbVieJun 2020
NCT03738215ADTEfficacy, 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 AloneP3completed759AbbVieNov 2018
NCT03739203ADTThe 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 AloneP3completed752AbbVieNov 2018
NCT04965272CAR aGAD Ph 2A 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 AloneP2withdrawn0AbbVieAug 2021
NCT03593213Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With SchizophreniaP3terminated587AbbVieJul 2018
NCT03430544Cariprazine Effects on Brain and Behavior in Cocaine Use DisorderP2terminated14Anna Rose Childress, Ph.D.Apr 2018
NCT02670538Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I DisorderP3completed493Forest LaboratoriesMar 2016
NCT02670551Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I DepressionP3completed488Forest LaboratoriesMar 2016
NCT01715805ADTEfficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)P3completed1,022Forest LaboratoriesNov 2012
NCT02165098Cariprazine: Comparison of Slow- and Immediate-release FormsP1completed160Gedeon Richter Plc.Jun 2014
NCT01838876Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive DisorderP3completed442Forest LaboratoriesApr 2013
NCT01412060A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With SchizophreniaP3completed765Forest LaboratoriesSep 2011
NCT01396447Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar DepressionP2completed584Forest LaboratoriesJul 2011
NCT01469377Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive DisorderP2completed819Forest LaboratoriesDec 2011
NCT01104792Long-term Study of Cariprazine in Patients With SchizophreniaP3completed752Forest LaboratoriesMay 2010
NCT01376076Effects of Cariprazine on Cardiac Repolarization in Patients With SchizophreniaP1completed129Forest LaboratoriesJun 2011
NCT01059539Long-term Safety and Tolerability of Cariprazine for Bipolar I DisorderP3completed403Forest LaboratoriesFeb 2010
NCT01058668Safety and Efficacy of Cariprazine for Bipolar I DisorderP3completed497Forest LaboratoriesFeb 2010
NCT01104766Safety and Efficacy of Cariprazine in Patients With SchizophreniaP3completed617Forest LaboratoriesApr 2010
NCT01104779Safety and Efficacy of Cariprazine in SchizophreniaP3completed446Forest LaboratoriesApr 2010
NCT01058096Safety and Efficacy of Cariprazine for ManiaP3completed323Forest LaboratoriesFeb 2010
NCT00854100Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive DisorderP2completed231Forest LaboratoriesJun 2009
NCT00839852A Study of Cariprazine in Patients With Chronic Stable SchizophreniaP2completed97Forest LaboratoriesMay 2009
NCT00852202Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar DepressionP2completed234Forest LaboratoriesJun 2009
NCT00862992Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With SchizophreniaP2completed34Tanabe Pharma CorporationApr 2008
NCT00694707RGH-188Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of SchizophreniaP2completed732Forest LaboratoriesJun 2008
NCT00488618RGH-188Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute ManiaP2completed238Forest LaboratoriesJun 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.

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